NCT00648921

Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's 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 fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Olanzapine Tablets 5 mg	5mg, single dose fasting
DRUG	Zyprexa® Tablets 5 mg	5mg, single dose fasting

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States