Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition
|ClinicalTrials.gov Identifier: NCT01578252|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : April 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fasting State||Drug: Ondansetron Tablets USP 8 mg Drug: Ondansetron Hydrochloride||Phase 1|
Objective of this pivotal study was to assess the bioequivalence between Test Product: Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zofran® (Ondansetron hydrochloride) 8 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 48 healthy adult subjects. In each study period, a single 8 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Ondansetron Tablets USP 8 mg With Zofran® 8 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.|
|Study Start Date :||May 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Experimental: Ondansetron Tablets USP 8 mg
Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India
Drug: Ondansetron Tablets USP 8 mg
8 mg tablet once a day
Other Name: Test Product
Active Comparator: Zofran®
Zofran® (Ondansetron Hydrochloride) Tablets 8 mg of M/s GlaxoSmithKline
Drug: Ondansetron Hydrochloride
8 mg tablet once a day
Other Name: Zofran®
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 5 months ]Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578252
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Tarang Shah, M.D.||Accutest Research Lab (I) Pvt. Ltd.|