NCT01523119

Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions

An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Ondansetron 8 mg Orally Disintegrating Tablets of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Zofran 8 mg ODT® Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) Manufactured by Cardinal Health, UK for GlaxoSmithKline USA, in Healthy, Adult, Human, Male Subjects Under Fed Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal health, UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed condition.

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ondansetron 8 mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA) with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron) manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male subjects under fed condition. During each period of the study after an overnight fast of at least 10 hours a high-fat high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, a single oral dose of either test or reference product was administered by placing the tablet on tongue till it dissolved and then swallowed it using 240 mL of drinking water at ambient temperature under supervision of a medical officer. During the course of the study, safety parameters including vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) were assessed and laboratory parameters of hematology and biochemistry were repeated at the end of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron	Orally Disintegrating Tablets 8 mg

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-07-01
• Completion: 2006-10-01
• First posted: 2012-02-01
• Last updated: 2012-02-09

Locations

1 site across 1 country: India