Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
|ClinicalTrials.gov Identifier: NCT01603134|
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fasting State||Drug: Allopurinol||Phase 1|
Objective of this pivotal study was to assess the bioequivalence between Test Product: Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy, adult, human male subjects in a randomized crossover study.
The study was conducted with 32 healthy adult male subjects. In each study period, a single 300 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 51 days including washout period of at 18 days between administrations of study drug in each study period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Comparative Bioequivalence Study of Allopurinol 300 mg Tablets USP With Zyloprim® 300 mg in Normal, Healthy, Adult, Human Male Subjects Under Fasting Condition.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Experimental: Allopurinol 300 mg Tablets USP
Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India
300 mg tablet once a day
Other Name: Test Product
Active Comparator: Zyloprim®
Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA,
300 mg tablet once a day
Other Name: Zyloprim®
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 6 months ]Area Under Curve (AUC) and Cmax Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603134
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Nirav Gandhi, M.D.||Accutest Research Lab (I) Pvt. Ltd.|