Status
Conditions
Treatments
About
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.) in healthy, adult, human, male, subjects under fed conditions.
Full description
The subjects received a single oral dose of either Test or Reference product, containing fixed-dose combination of Quinapril 20 mg and Hydrochlorothiazide 25 mg after an overnight fast of at least 10 hours. The study drug was administered as per the SAS generated Randomization Code, 30 minutes after serving of a high-fat high-calorie breakfast under supervision of a trained Medical Officer in each period.Blood samples were collected predose and at intervals over 72 hours after each dose. A 7-day interval was maintained between each dosing in the Study Periods I-IV.
During the course of the study safety parameters assessed were vital signs, physical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated and sodium & potassium levels were estimated at the 24 hours post dose of the last period of the study.
A total of 40 subjects were randomized to receive fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets and 37 subjects completed all the four periods of the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
40 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal