Abstract:
PURPOSE:The purpose of this study was to evaluate the bioavailability of hydroxyprogesterone caproate (HPC) administered as a subcutaneous injection in the back of the upper arm using a prefilled autoinjector syringe with a 27-gauge needle compared with standard intramuscular injection in the gluteus maximus using a 21-gauge needle. METHODS:Healthy postmenopausal women 50 to 75 years old were randomized in a parallel group design to receive a single SC injection of 1.1 mL (275-mg total dose) of preservative-free HPC administered using an autoinjector in the back of the upper arm or a single IM injection of 1 mL (250-mg total dose) of preservative-free HPC administered in the gluteus maximus. Blood samples were collected through 1008 hours (42 days) after injection. The primary measures were the Cmax, AUC0-t, and AUC0-∞. Secondary measures were Tmax, ke, t½, and injection site reactions captured as a treatment-emergent adverse event. FINDINGS:The pharmacokinetic population consisted of 90 individuals; 45 received subcutaneous administration and 45 received intramuscular administration. Geometric mean whole blood concentrations of HPC were comparable between administration regimens. Subcutaneous administration resulted in a higher geometric mean Cmax than intramuscular administration (7.88 vs 6.91 ng/mL), but median Tmax values were comparable (48.1 vs 49.7 hours). The least square geometric mean ratios for AUC0-168), AUC0-t, and AUC0-∞ were 102.89%, 110.25%, and 113.51%, respectively, with all 90% CIs within the 80.0% to 125.0% window that defined bioequivalence. The ratio for Cmax was 113.95% with a 90% CI of 91.94% to 141.23% but with substantial overlap of individual values between administration regimens. The geometric mean t½ of HPC was 212 hours for the subcutaneous administration and 188 hours for the intramuscular administration. The most common treatment-emergent adverse event was injection site pain (subcutaneous, 37.3%; intramuscular, 8.2%), described as mild (85%) to moderate (15%). IMPLICATIONS:Administration of HPC by SC injection of 1.1 mL (275 mg) via autoinjector is bioequivalent to IM injection of 1.0 mL (250 mg). ClinicalTrials.gov identifier: NCT02940522.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Krop J,Kramer WGdoi
10.1016/j.clinthera.2017.10.020subject
Has Abstractpub_date
2017-12-01 00:00:00pages
2345-2354issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(17)31060-3journal_volume
39pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Opiates, acetaminophen, nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2-selective inhibitors such as rofecoxib are used in the treatment of acute pain because of their anti-inflammatory and/or analgesic properties. Rofecoxib has demonstrated an improved gastrointestinal safet...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(04)90076-8
更新日期:2004-05-01 00:00:00
abstract:BACKGROUND:Despite increasing investigation in the area of cardiovascular instability in preterm infants, huge gaps in knowledge remain. None of the current treatments for hypotension, including the use of inotropic agents, have been well studied in the preterm population, and data regarding safety and efficacy are lac...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2006.09.006
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND:During the past decade, there has been some progress in the pharmacotherapy of schizophrenia and schizoaffective disorder. Current evidence supports the use of various second-generation, or atypical, antipsychotic medications, although few of these agents have been associated with long-term efficacy and tole...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2010.01.021
更新日期:2010-01-01 00:00:00
abstract:PURPOSE:The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefor...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.07.015
更新日期:2015-09-01 00:00:00
abstract::This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the...
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)80087-5
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:In 2002, fixed-dose combination therapy (FDCT) with rosiglitazone maleate plus metformin hydrochloride became available for the treatment of type 2 diabetes mellitus (DM-2) in subjects whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione. FDCT allows a reduced pill burden and a...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2004.12.018
更新日期:2004-12-01 00:00:00
abstract:OBJECTIVE:This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy. METHODS:This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced ti...
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.2004.11018
更新日期:2004-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-03-01 00:00:00
abstract::The efficacy and safety of Naprelan (naproxen sodium) 1000 mg once daily (QD) and nabumetone 1500 mg QD were compared in a multicenter, randomized, parallel-group, placebo-controlled, double-masked, 4-week study of adult outpatients with active osteoarthritis (OA) of the knee. Nabumetone 1500 mg was chosen for compari...
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(97)80090-2
更新日期:1997-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/S0149-2918(99)80053-8
更新日期:1999-10-01 00:00:00
abstract:BACKGROUND:Many patients with asthma require an inhaled long-acting beta(2)-agonist (LABA) in addition to an inhaled corticosteroid to adequately control their disease. OBJECTIVE:The purpose of this study was to assess the long-term tolerability of a salmeterol xinafoate/ fluticasone propionate (SFC) hydrofluoroalkane...
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.2007.07.021
更新日期:2007-07-01 00:00:00
abstract::Allylestrenol was used to treat 375 women with threatened pregnancies. Results show that this drug is capable of maintaining pregnancy in a large series of ambulant patients and is safe for both mother and child. Allylestrenol does not maintain pregnancy if placental dysfunction is present, however. Newborns whose mot...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1980-01-01 00:00:00
abstract:PURPOSE:The purposes of this review are to describe the pathogenesis of mucormycosis and to address recent research advances in understanding the mechanisms of fungal invasion and dissemination. METHODS:Studies and reviews published in the PubMed and ClinicalTrials.gov databases until December 2017 that explored or re...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2018.03.009
更新日期:2018-06-01 00:00:00
abstract::The pharmacokinetics of cimetidine were studied in three newborn infants with reflux esophagitis or stress ulcer. One infant was given 5 mg/kg intravenously (IV), one was given 10 mg/kg IV, and one was given 10 mg orally. Serum concentrations 30 minutes after administration were 1.2 micrograms/ml, 5 micrograms/ml, and...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract:PURPOSE:Intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are associated with several potential health benefits, but standard ethyl ester (EE) formulations of these ω-3 fatty acids require the co-ingestion of fat for adequate absorption. The objective of this research was to assess the relative bioa...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2018.10.014
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:Dipeptidyl peptidase-IV (DPP-IV) inhibitors represent a new class of oral antihyperglycemic agents. Sitagliptin is an orally active and selective DPP-IV inhibitor currently in Phase III development for the treatment of type 2 diabetes mellitus. OBJECTIVE:The aim of this study was to assess the pharmacokinet...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.01.015
更新日期:2006-01-01 00:00:00
abstract:PURPOSE:Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combinat...
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.2018.03.010
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND:Several studies have reported increased health care resource use among hypertensive patients with uncontrolled blood pressure (BP). OBJECTIVE:The purpose of this study was to investigate the relationship between BP control and health care resource use. METHODS:Data were obtained from the Caring for 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/s0149-2918(01)80143-0
更新日期:2001-10-01 00:00:00
abstract:BACKGROUND:To date, few postmarketing studies have addressed whether long-term prophylactic treatment with second-generation antidepressants (ADs) delays depressive episodes in patients with bipolar disorder. OBJECTIVE:The aim of this study was to compare the risk of depressive relapse between patients with bipolar di...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.06.011
更新日期:2006-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1983-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.05.019
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:Tapentadol hydrochloride is a centrally acting oral analgesic approved by the US Food and Drug Administration in November 2008 for the treatment of moderate to severe acute pain. It is available as immediate-release 50-, 75-, and 100-mg tablets. OBJECTIVE:The purpose of this article is to review animal stud...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2009.12.003
更新日期:2009-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.04.006
更新日期:2012-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2012.09.012
更新日期:2012-11-01 00:00:00
abstract:PURPOSE:Efavirenz exhibits high interindividual variability in plasma concentrations, leading to unpredictable efficacy and toxicity. Polymorphism of CYP2B6 516G > T has been found to predominantly contribute to efavirenz variability. However, dosage recommendations incorporating CYP2B6 516G > T polymorphism have not b...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.04.013
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:Numerous reviews and meta-analyses of the antidepressant literature in major depressive disorders (MDD), both acute and maintenance, have been published, some claiming that antidepressants are mostly ineffective and others that they are mostly effective, in either acute or maintenance treatment. OBJECTIVE:T...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.019
更新日期:2011-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.03.008
更新日期:2009-03-01 00:00:00
abstract:BACKGROUND:In Taiwan, a policy of separation of prescribing and dispensing practices of practitioners at Western medical and dental clinics was implemented on an incremental basis in 1997. The purpose of this policy was to promote pharmacists' autonomy and increase the transparency and safety of prescribing medications...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.08.005
更新日期:2006-08-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.08.012
更新日期:2015-10-01 00:00:00
abstract:PURPOSE:Antihypertensive drugs are prescribed to patients with chronic kidney disease (CKD) for their cardioprotective and renoprotective effects. Nationally representative information on the use of antihypertensive drugs among CKD patients is limited. The purpose of this study was to assess the utilization patterns of...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.11.011
更新日期:2015-01-01 00:00:00