Abstract:
OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After administration, serial blood samples were collected over a 24-hour period and the plasma concentration of ambroxol was subsequently measured using high performance liquid chromatography with ultraviolet detection after liquid-liquid extraction. Pharmacokinetic parameters were analysed by a noncompartmental pharmacokinetic model and compared between formulations using analysis of variance with a significance level of 0.05. RESULTS:The point estimates (90% CI) of the area under the plasma concentration-time curve (AUC) and peak plasma concentration (C(max)) ratios between lozenge and commercial tablet were 1.07 (0.89 to 1.28) and 1.20 (1.04 to 1.40), respectively. The point estimate (90% CI) of the difference between formulations for time to C(max) was 0.40 (-0.20 to 1.00). CONCLUSION:The two formulations under test were not bioequivalent based on the stipulated bioequivalence criteria. The bioavailability from the ambroxol lozenge might be better, since the 90% CI of the AUC(0-infinity) fell outside the bioequivalence range, and its range was narrower. The difference in rate of absorption was not conclusive because ambroxol was delivered from the lozenge by two parallel processes, namely absorption via oral and gastrointestinal mucosa. The additional oral mucosal absorption might not only contribute more absorption but also introduce variability compared with that of tablet administration. The relative importance of oral versus gastrointestinal mucosal absorption of ambroxol from the lozenge formulation, and the clinical significance of this, requires further study.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Rojpibulstit M,Kasiwong S,Juthong S,Phadoongsombat N,Faroongsarng Ddoi
10.2165/00044011-200323040-00007subject
Has Abstractpub_date
2003-01-01 00:00:00pages
273-80issue
4eissn
1173-2563issn
1179-1918pii
2347journal_volume
23pub_type
杂志文章abstract::Iobitridol is a water-soluble, non-ionic, monomeric, low-osmolar, iodine-based contrast medium in which the potential for interaction with membrane proteins in the body has been minimized by stable masking of the molecule's lipophilic tri-iodinated benzene ring. It is approved in various countries worldwide for use as...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-013-0055-3
更新日期:2013-02-01 00:00:00
abstract::The role of postprandial hyperglycaemia in contributing to the risk of both micro- and macrovascular complications in patients with diabetes mellitus is being increasingly recognized. In type 2 diabetes, there is a progressive shift in the relative contributions of postprandial and fasting hyperglycaemia to the overal...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/00044011-200828040-00001
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period. PATIENTS AND M ethods: Overall efficacy data were reported for type 1 and type 2 diabetes, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525100-00004
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:For patients with hypertension, effective 24-hour blood pressure (BP) control is vital to ensure protection against the early morning surge in BP and the associated increased risk of cardiovascular events. The aim of this analysis was to assess the 24-hour antihypertensive efficacy of olmesartan medoxomil (2...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626040-00002
更新日期:2006-01-01 00:00:00
abstract::The Editor-in-Chief has retracted this article because two of the three studies [1, 2] included in the meta-analysis (cited as references 11 and 12) have been retracted due to fabrication of the data, which has rendered the results of this meta-analysis invalid. ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,撤回出版物
doi:10.1007/s40261-018-0643-3
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Pegylated interferon (peg-IFN)-α2a and -α2b show different pharmacokinetic properties but are used interchangeably for hepatitis C treatment in traditional dual combinations and with newer agents. We assessed whether peg-IFN antiviral effects vary with peg-IFN subtype, affecting viral response...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0241-y
更新日期:2014-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200222020-00007
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the sam...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0441-8
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Hypertension remains a major global health problem, and evidence suggests that the majority of patients will require two or more antihypertensive agents in order to reach specified BP targets. Combining two drugs from different classes has the potential to target different aspects of hypertensi...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929070-00001
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:As a β-adrenoceptor antagonist (β-blocker), esmolol can reduce cardiac output and the phosphodiesterase III inhibitor milrinone has been shown to improve heart contractility in patients with septic shock. This study was performed to assess the effects of esmolol combined with milrinone in patie...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0325-3
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:There is little information on the effects of trandolapril on renal function when used in Canadian general practice. We evaluated the use and blood pressure (BP) lowering effectiveness of trandolapril-based therapies in Canadian conditions of actual care and attempted to capture assessments of...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-013-0092-y
更新日期:2013-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Tegoprazan is one of the potassium-competitive acid blockers (P-CABs). It exhibits its anti-secretory effects by competitively and reversibly blocking the availability of K+ of the H+, K+-ATPase. This study was designed to investigate the safety and pharmacokinetics of tegoprazan in healthy Ch...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00986-4
更新日期:2021-01-01 00:00:00
abstract:INTRODUCTION:The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. OBJECTIVE:The aim of this study was to compare four ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0463-2
更新日期:2017-01-01 00:00:00
abstract::Twenty-four patients with vascular disorders, randomly divided into 3 dosage groups of 8 patients, were treated with a single oral dose of sulodexide (50, 100 or 200mg) and placebo. Tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI-1) activity and antigen, euglobulin lysis time, α2-antiplasmin,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199510030-00005
更新日期:1995-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study was performed in healthy Chinese subjects to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of a novel injection formulation of dexlansoprazole in the context of single and multiple administration, compared with the original lansoprazole injection. METHODS:H...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00824-2
更新日期:2019-10-01 00:00:00
abstract:OBJECTIVE:Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evalua...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200727010-00005
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide. OBJECTIVE:To investigate potential drug-drug interactions (DDIs) between lacosamide and digoxin, this phase I, multiple-dose, randomised, double-blind, placebo-controlled, crossover trial assessed the pharmacokineti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0180-7
更新日期:2014-05-01 00:00:00
abstract::The superior vena cava (SVC) syndrome occurs when obstruction of this vessel interrupts venous return of blood from the head, upper extremities and thorax to the right atrium. Most cases of SVC syndrome result from neoplasia, especially from lung cancer, but other non-cancer-associated causes may include fibrosis caus...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200727070-00007
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE:To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate p...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323010-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The hematological side effects associated with mycophenolic acid (MPA) are relatively common and have severe consequences. The majority of literature data have not shown clear consistency in the MPA exposure-neutropenia relationship. We hypothesized that (i) adult de novo kidney transplant rec...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0694-5
更新日期:2018-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Matrix metalloproteinases (MMPs) are proteases with different biological and pathological activities, and many have been linked to several diseases. Targeting individual MMPs may offer a safer therapeutic potential for several diseases. We assessed the safety, tolerability, and pharmacokinetic...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00981-9
更新日期:2021-01-01 00:00:00
abstract::In an in vivo rat model of myocardial infarction, opioid receptor stimulation has been observed to result in a reduction in infarct size similar to that produced by ischaemic preconditioning. The ability of glibenclamide to abolish this effect suggests an involvement of the myocardial ATP-sensitive potassium (K(ATP)) ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815050-00009
更新日期:1998-01-01 00:00:00
abstract::Heart rate is an established prognostic marker for longevity and is an important contributor in the pathophysiology of various cardiovascular diseases, including ischemic heart disease and heart failure. Most ischemic episodes are triggered by an increase in heart rate, which causes an imbalance between myocardial oxy...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-016-0472-1
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Recently the PatenT (Prevalence, awareness, treatment and control of hypertension in Turkey) study showed that while the prevalence of hypertension in Turkey is high, effective control of BP is infrequently achieved. This study investigated the efficacy and safety of quinapril (as monotherapy o...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200727090-00003
更新日期:2007-01-01 00:00:00
abstract:OBJECTIVE:Central nervous effects of oral anticholinergics may limit the success of incontinence therapy and patient compliance. Only a few studies investigating this topic are available. This study was conducted to determine whether oral anticholinergics alter sleep and psychometric test parameters. DESIGN:Randomised...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323060-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Muscle wasting is common and insidious in end-stage renal disease (ESRD). Loss of muscle quantity and quality reduces quality of life and increases mortality in ESRD patients. Additionally, secondary hyperparathyroidism (SHPT) causes muscle atrophy. Meanwhile, vitamin D, which is used for SHPT treatment, pla...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0132-7
更新日期:2013-11-01 00:00:00
abstract:BACKGROUND:Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. OBJECTIVE:This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant populati...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11538860-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-00743-8
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract. DA-6034 has been shown to be effective in an IBD model and has demonstrated a good toxicological profile in preclinical studies. This study evaluated the tolerability, safety and pharmacokinetics...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0147-0
更新日期:2014-01-01 00:00:00