NCT01578252

Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.

Detailed description

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.

Conditions

• Fasting State

Interventions

Type	Name	Description
DRUG	Ondansetron Tablets USP 8 mg	8 mg tablet once a day
DRUG	Ondansetron Hydrochloride	8 mg tablet once a day

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-04-16
• Last updated: 2012-04-16

Locations

1 site across 1 country: India