Status:

TERMINATED

Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg

Lead Sponsor:

Mylan Pharmaceuticals Inc

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration u...

Eligibility Criteria

Inclusion

  • healthy, adult subjects, 18 years and older
  • able to swallow medication

Exclusion

  • institutionalized subjects
  • history of any significant disease
  • use of any prescription or OTC medications within 14 days of start of study
  • received any investigational products within 30 days prior to start of study

Key Trial Info

Start Date :

May 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00647972

Start Date

May 1 2003

Last Update

April 23 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kendle International Inc.

Morgantown, West Virginia, United States, 26505