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

Mylan

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Zyprexa® Tablets 20 mg; Drug: Olanzapine Tablets 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647972

OLAN-02136

Details and patient eligibility

About

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 under fasting conditions.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Experimental group

Description:

Olanzapine Tablets 20 mg

Treatment:

Drug: Olanzapine Tablets 20 mg

2

Active Comparator group

Description:

Zyprexa® Tablets 20 mg

Treatment:

Drug: Zyprexa® Tablets 20 mg