NCT01523093

Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting 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 Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc,) With Zofran ODT® 8 mg Orally Disintegrating Tablets (Containing 8 mg of Ondansetron) of GlaxoSmithKline in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 39 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 Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg orally disintegrating tablets of GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting 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 Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® orally disintegrating tablets (containing 8 mg of ondansetron) of GlaxoSmithKline in healthy, adult, human, male subjects under fasting condition. During each period of the study after an overnight fast of at least 10 hours, 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 8mg

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