Abstract:
BACKGROUND:Due to Mexico's complicated socioeconomic environment, causing a high occurrence of >1 person sharing a single room, respiratory conditions are spread easily. Respiratory conditions are the main reason for consultation with a physician. The most frequent symptoms are throat soreness and cough; therefore, a new formulation combining loratadine and ambroxol hydrochloride was designed to treat these 2 major symptoms. The combination is expected to provide relief when coprescribed with more specific therapies, such as antibiotics. OBJECTIVE:This study determined the pharmacokinetic profile of single-dose loratadine-ambroxol hydrochloride combination therapy versus each component given separately. The analyses included descarboethoxyloratadine (DCL), the primary active metabolite of loratadine. METHODS:This was a 4-week, single-center, randomized, open-label, 3-period crossover study in adult male volunteers aged 18 to 50 years and in good general health. Subjects were randomized to receive single doses of treatment A (2 loratadine 5-mg tablets + ambroxol 30-mg tablets), B (2 ambroxol 30-mg tablets), or C (1 loratadine 10-mg tablet) in 1 of 3 sequences (ABC, BCA, or CAB) per period. A 14-day washout period separated each treatment period. Plasma concentration-time data curves for each subject and treatment were analyzed by noncompart-mental methods to obtain values for area under the curve (AUC), maximum plasma concentration (C(max)), and time to reach C(max) (T(max)). RESULTS:Thirty subjects (mean [SD] age, 22.5 [2.6] years) were enrolled. All treatments were well tolerated. Formulations A and C produced similar loratadine and DCL AUC from time 0 to 24 hours (AUC(0-24)) values, but showed slightly high C(max). values for loratadine and slightly low C(max) values for DCL, indicating failure to demonstrate bioinequivalence. Formulations A and B produced similar ambroxol C(max), T(max), and AUC(0-24) values. CONCLUSIONS:In this population of healthy mate volunteers, results showed the bioavailability of loratadine and ambroxol from the new formulation and did not show impairment of absorption when the drugs were formulated in a combination tablet.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Villacampa J,Alcántar F,Rodríguez JM,Morales JM,Herrera J,Rosete Rdoi
10.1016/s0149-2918(03)80215-1subject
Has Abstractpub_date
2003-08-01 00:00:00pages
2225-32issue
8eissn
0149-2918issn
1879-114Xpii
S0149291803802151journal_volume
25pub_type
临床试验,杂志文章,随机对照试验abstract:PURPOSE:We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. METHODS:There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.03.020
更新日期:2017-05-01 00:00:00
abstract:PURPOSE:Prostate cancer is the second most common cancer among men worldwide. In the past 10 years in Iran, prostate cancer has increased and become more common among hormone-related cancers. As the percentage of seniors in the population increases, the economic burden of this cancer will likely increase significantly....
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.11.001
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chron...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.11.006
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:Communicating potential benefits and harm to patients and payers is essential for high-quality care. However, there are no published guidelines or consensuses on how to communicate potential benefits and harm to patients and payers. OBJECTIVE:The goal of this review was to identify key elements for communic...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.013
更新日期:2011-12-01 00:00:00
abstract::Immediate complications of trauma and shock include right heart failure, acute respiratory distress syndrome, coagulopathy, brain edema, small bowel dysfunction, renal failure, and immune dysfunction. Nosocomial infections are also common in trauma patients. These infections are the combined result of a compromised ho...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1990-01-01 00:00:00
abstract:PURPOSE:Globally, the management of chronic heart failure (CHF) challenges health systems. The high burden of disease and the costs associated with hospitalization adversely affect individuals, families, and society. Improved quality, access, efficiency, and equity of CHF care can be achieved by using multidisciplinary...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.08.021
更新日期:2015-10-01 00:00:00
abstract:BACKGROUND:Antimicrobial prophylaxis in select neutropenic patients has reduced fever, infection rates, hospital length of stay, and hospitalization rates. Guidelines from the Infectious Diseases Society of America recommend the consideration of prophylaxis with a fluoroquinolone in patients at high risk for infection ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.04.013
更新日期:2014-06-01 00:00:00
abstract:BACKGROUND:Apixaban (5 mg BID), dabigatran (available as 150 mg and 110 mg BID in Europe), and rivaroxaban (20 mg once daily) are 3 novel oral anticoagulants (NOACs) currently approved for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVE:The objective of this study was to evaluate the cost-effect...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.12.011
更新日期:2014-02-01 00:00:00
abstract::A parallel-group, randomized, double-blind, forced-titration, multicenter study was done to compare the efficacy and safety of once-daily nifedipine coat-core (NIF CC) and once-daily nifedipine gastrointestinal therapeutic system (NIF GITS) dosed in the fasting state in patients with mild-to-moderate essential hyperte...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/0149-2918(95)80028-x
更新日期:1995-03-01 00:00:00
abstract:BACKGROUND:Antidepressants have been commonly used by women of childbearing age. Recent studies suggest that paroxetine, a selective serotonin reuptake inhibitor (SSRI), might specifically increase teratogenic risk. OBJECTIVES:The purpose of this study was to quantify first-trimester exposure to paroxetine and birth d...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2007.05.003
更新日期:2007-05-01 00:00:00
abstract:BACKGROUND:The efficacy of topiramate (TPM) as an adjunctive treatment for epilepsy has been established in placebo-controlled clinical trials. Clinical trials of antiepileptic monotherapy usually evaluate low and high doses of study drug or compare study drug with another active agent. OBJECTIVE:This article reviews ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(08)80045-8
更新日期:2008-07-01 00:00:00
abstract:BACKGROUND:Dual antiplatelet therapy with a thienopyridine (ticlopidine or clopidogrel) and aspirin is used to reduce the risk of late stent thrombosis and complications (myocardial infarction [MI] and death) after placement of a drug-eluting stent (DES). OBJECTIVE:This article reviews available clinical efficacy and ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.01.003
更新日期:2010-12-01 00:00:00
abstract::The United States Pharmacopeia (USP) Practitioners' Reporting Network utilized nearly three decades of experience to design and develop a nationwide, anonymous, Internet-accessible service for hospitals to report and benchmark medication errors (also known as "preventable adverse drug events"). As nationwide experient...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(98)80008-8
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:Ezetimibe (EZE) is a cholesterol-lowering drug that inhibits absorption of dietary and biliary cholesterol across the intestinal wall without affecting absorption of bile acids, fatty acids, fat-soluble vitamins, or triglycerides. It has a complementary mechanism of action to the statins, which inhibit chole...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2005.02.011
更新日期:2005-02-01 00:00:00
abstract::The in vitro activity of Ro 09-1428, a new parenteral cephalosporin, was compared with that of other beta-lactams and aminoglycosides in 1230 clinical isolates from 1028 consecutive patients. Using an agar dilution method, the drugs were tested against 625 isolates of Enterobacteriaceae, 68 Pseudomonas aeruginosa, 36 ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1992-07-01 00:00:00
abstract:PURPOSE:The goal of this study is to identify and compare all direct costs of intravenous and subcutaneous rituximab given to patients with diffuse large B-cell lymphoma in the Netherlands. METHODS:Using a prospective, observational, bottom-up microcosting study, we collected primary data on the direct medical costs o...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.05.342
更新日期:2017-06-01 00:00:00
abstract::The optimal antibiotic therapy for patients with acute bacterial exacerbations of chronic bronchitis (ABECB) who have failed to respond to previous oral antimicrobial therapy is not known; however, newer macrolide and fluoroquinolone antibiotics may be appropriate. This multicenter, randomized, double-masked, double-d...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/S0149-2918(99)80017-4
更新日期:1999-06-01 00:00:00
abstract:PURPOSE:Children with normal urinary tract anatomy and function and highly recurrent urinary tract infection (rUTI) may have a lack of alternatives when antibiotic prophylaxis and "watchful waiting" approaches fail. This retrospective review reports the outcomes in children who received a fluoroquinolone/probiotic comb...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.06.018
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.02.007
更新日期:2009-02-01 00:00:00
abstract:PURPOSE:The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2016.03.004
更新日期:2016-05-01 00:00:00
abstract::Patients with diabetes are responsible for the vast majority of management requirements of their condition. However, their ability and motivation to engage in required self-management behaviors may be mitigated by multiple intrinsic and extrinsic factors. Intrinsic barriers include attitudes and health beliefs, limite...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.01.002
更新日期:2013-02-01 00:00:00
abstract:BACKGROUND:Panitumumab, formerly known as ABX-EGF, was the first recombinant human immunoglobulin G2 monoclonal antibody approved by the US Food and Drug Administration for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer (mCRC) refractory to fluoropyrimidine-, oxa...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2008.01.014
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Risedronate 5 mg/d is approved by the US Food and Drug Administration for the treatment and prevention of postmenopausal osteoporosis. Once-monthly dosing options might increase treatment compliance and persistence. OBJECTIVE:The aim of this study was to compare the tolerability and efficacy of 3 once-month...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2009.02.012
更新日期:2009-02-01 00:00:00
abstract:BACKGROUND:During the past 5 years, there has been much concern about the safety of and ease of access to drugs that are unavailable without a prescription in the United States but are manufactured and can be purchased over the counter (OTC) in Mexico. However, based on a literature search, studies have not been perfor...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2005.05.007
更新日期:2005-05-01 00:00:00
abstract:PURPOSE:Rosuvastatin, a hydroxy methylglutaryl coenzyme A reductase inhibitor; telmisartan, an angiotensin receptor blocker; and amlodipine, a calcium channel inhibitor, are commonly prescribed together for the treatment of hypertension nonresponsive to monotherapy and accompanied by dyslipidemia. However, the pharmaco...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2016.06.011
更新日期:2016-08-01 00:00:00
abstract:PURPOSE:New therapies, including daratumumab plus lenalidomide plus dexamethasone (DRd) and daratumumab plus bortezomib plus dexamethasone (DVd), have recently been approved in the United States for patients with multiple myeloma (MM) who have received at least 1 prior line of therapy. However, few treatments have been...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/j.clinthera.2018.01.014
更新日期:2018-03-01 00:00:00
abstract:PURPOSE:During amyotrophic lateral sclerosis progression, up to 85% of patients develop dysphagia. Riluzole oral suspension 50 mg/10 mL is bioequivalent to riluzole 50-mg film-coated tablets administered orally under fasting conditions. Here, we compare the bioavailability of a single 50-mg dose of riluzole oral suspen...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2019.09.016
更新日期:2019-12-01 00:00:00
abstract:BACKGROUND:Meclofenoxate hydrochloride is a psychostimulant in the nootropic agent group available in capsule and tablet formulations approved for traumatic cataphora, alcoholic poisoning, anoxia neonatorum, and children's enuresis in China. Although these 2 generic formulations are marketed in China, information regar...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2008.09.013
更新日期:2008-09-01 00:00:00
abstract::Serum creatinine and beta 2-microglobulin levels, endogenous creatinine clearance, the urinary beta 2-microglobulin excretion rate, and urinary protein levels were monitored serially in 29 patients with duodenal ulcers randomly allocated to receive eight weeks of treatment with cimetidine, ranitidine, or an antacid. A...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:BACKGROUND:Fever in children is a common and usually benign symptom. It is known that antipyretic treatment is ineffective in the prevention of simple febrile seizures. Caregivers' administration of antipyretic medications to children has been reported, but data concerning the formulations used, actual doses administer...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.05.010
更新日期:2006-05-01 00:00:00