Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition
|Fasting State||Drug: Carvedilol Tablets USP 12.5 mg Drug: Carvedilol||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Carvedilol Tablets USP 12.5 mg With Coreg® 12.5 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.|
- Bioequivalence is based on Cmax and AUC parameters.Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose. [ Time Frame: 5 months ]
Bioequivalence was concluded if:
The 90% confidence interval of geometric mean ratio of Cmax, AUC0-t and AUC0-inf between test and reference product fall within the range of 80.00 % to 125.00 % for Carvedilol.
|Study Start Date:||July 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Carvedilol Tablets USP 12.5 mg
Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India
Drug: Carvedilol Tablets USP 12.5 mg
12.5mg tablet once a day
Other Name: Test Product
Active Comparator: Coreg®
Coreg® (Carvedilol Tablets) 12.5 mg of M/s GlaxoSmithKline
12.5mg tablet once a day
Other Name: Coreg®
Objective of this pivotal study was to assess the bioequivalence between Test Product: Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Coreg® (Carvedilol Tablets) 12.5 mg Tablets of M/s GlaxoSmithKline, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 42 healthy adult subjects. In each study period, a single 12.5 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577914
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Tarang Shah, M.D.||Accutest Research Lab (I) Pvt. Ltd.|