Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of separate tablets in healthy Korean subjects

2019 ◽  
Vol 57 (12) ◽  
pp. 612-622
Author(s):  
Jeong-Soo Park ◽  
Ji-Young Jeon ◽  
Min-Gul Kim
Keyword(s):  
Bioequivalence Study ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Amlodipine Besylate ◽  
Dose Combination ◽  
Rosuvastatin Calcium ◽  
Separate Tablets

scholarly journals Bioequivalence of a Fixed-Dose Combination Tablet of the Complete Two-Drug Regimen of Dolutegravir and Rilpivirine for Treatment of HIV-1 Infection

2018 ◽  
Vol 62 (9) ◽  
Author(s):  
Rashmi Mehta ◽  
Allen Wolstenholme ◽  
Kristin Di Lullo ◽  
Caifeng Fu ◽  
Shashidhar Joshi ◽  
...  
Keyword(s):  
Statistical Power ◽  
Drug Regimen ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Reference Treatment ◽  
Dose Combination ◽  
Hiv 1 ◽  
Test Treatment ◽  
Separate Tablets

ABSTRACTA complete 2-drug regimen of dolutegravir at 50 mg and rilpivirine at 25 mg was approved to treat HIV-1 infection in virologically suppressed patients after demonstrating acceptable efficacy and tolerability. This study investigated the bioequivalence and pharmacokinetics of the fixed-dose combination tablet compared with those of separate tablets. Secondary endpoints were the tolerability and safety of the fixed-dose combination tablet. In this open-label, randomized-sequence, 2-way crossover trial, single doses of the fixed-dose combination tablet (the test treatment) and the combination of separate tablets (the reference treatment) were administered to healthy adults after a moderate-fat meal, with a 21-day washout between treatments. Pharmacokinetic samples were collected through 12 days after dosing. The primary endpoints were the area under the plasma concentration-time curve (AUC) and the maximum concentration of drug in plasma (Cmax). The study employed a prespecified sample size reestimation based on a blind midpoint review ofCmaxvariability to update the enrollment size to achieve statistical power. Of 118 participants enrolled, 113 received both treatments and underwent pharmacokinetic assessment. The 90% confidence intervals for the geometric least-squares mean ratios for the AUC from 0 h to infinity, the AUC from 0 h to the last quantifiable measurement, andCmax(test treatment versus reference treatment) were within the bioequivalence range of 0.80 to 1.25 for both drugs, indicating bioequivalence. In this study, a single dose of either treatment was well tolerated overall, with 4% (n= 5) and 3% (n= 3) of participants reporting adverse events considered related to the test and reference treatments, respectively. The dolutegravir-rilpivirine fixed-dose combination tablet is bioequivalent to a combination of separate tablets, and no new safety signals emerged. (This study has been registered at ClinicalTrials.gov under identifier NCT02741557.)

Bioequivalence Study of a Fixed Dose Combination of Nitazoxanide and Ofloxacin in Indian Healthy Volunteers

2011 ◽  
Vol 57 (10) ◽  
pp. 679-683
Author(s):  
Sangita Agarwal ◽  
W. Solomon ◽  
K. Gowda ◽  
P. Selvan ◽  
Debotri Ghosh ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Bioequivalence Study ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination

Pharmacokinetics and Bioequivalence Study of a Fixed Dose Combination of Rabeprazole and Itopride in Healthy Indian Volunteers

2011 ◽  
Vol 59 (09) ◽  
pp. 451-454 ◽  
Author(s):  
Bijay Sahoo ◽  
Ayan Das ◽  
Sangita Agarwal ◽  
Uttam Bhaumik ◽  
Anirbandeep Bose ◽  
...  
Keyword(s):  
Bioequivalence Study ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination

Bioequivalence Study of a Sustained Release Fixed Dose Combination Capsule Containing Esomeprazole and Domperidone in Healthy Subjects

2011 ◽  
Vol 57 (05) ◽  
pp. 274-277
Author(s):  
Sangita Agarwal ◽  
KadajjiVeeran Gowda ◽  
Uttam Mandal ◽  
Debotri Ghosh ◽  
Anirbandeep Bose ◽  
...  
Keyword(s):  
Sustained Release ◽  
Healthy Subjects ◽  
Bioequivalence Study ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination
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