Single-Dose Food In Vivo Bioequivalence Study of Olanzapine Tablets (5 mg; Mylan) and Zyprexa® Tablets (5 mg; Eli Lilly) in Healthy Volunteers

NCT00647777 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fed conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2003-06
Completion	2003-07

Conditions

• Healthy

Interventions

• Olanzapine Tablets 5 mg
• Zyprexa® Tablets 5 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States