Single-Dose Fasting In Vivo Bioequivalence Study of Ondansetron Orally Disintegrating Tablets (8 mg; Mylan) to Zofran ODT® Tablets (8 mg; GlaxoSmithKline) in Healthy Volunteers

NCT00649363 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fasting conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	28
Start date	2005-07
Completion	2005-07

Conditions

• Healthy

Interventions

• Ondansetron Orally Disintegrating Tablets 8 mg
• Zofran ODT® Tablets 8 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States