NCT00647972

TerminatedPhase 1

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

Mylan Pharmaceuticals Inc Source

Mylan Pharmaceuticals Inc

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

OLAN-02136

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2003

Actual (reported)

Study Completion

Not reported

Date not reported

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 under fasting conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 32 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2003
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 23, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 144 hours

Study Arms (2)

1

EXPERIMENTAL

Olanzapine Tablets 20 mg

Drug: Olanzapine Tablets 20 mg

2

ACTIVE COMPARATOR

Zyprexa® Tablets 20 mg

Drug: Zyprexa® Tablets 20 mg

Interventions

Olanzapine Tablets 20 mgDrug

20mg, single dose fasting

1

Zyprexa® Tablets 20 mgDrug

20mg, single dose fasting

2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Thomas S Clark, M.D.
Kendle International Inc.
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1Completed

NCT00648661

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Phase 1Completed

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

Contact the study team to confirm eligibility.

Primary Completion

May 2003

Actual (reported)

Last Updated

April 23, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00647972
Data provider: ClinicalTrials.gov
Source updated: 2024-04-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:32 UTC

Locations

US(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations