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NCT00648921 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00648921 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 30 participants.

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The verdict

NCT00648921, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • DRUG Olanzapine Tablets 5 mg
  • DRUG Zyprexa® Tablets 5 mg

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2003-06
Est. Completion 2003-07
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648921

The ClinicalTrials.gov registry entry for NCT00648921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Olanzapine Tablets 5 mg is the first listed.

NCT00648921 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00648921 about?

NCT00648921 is a clinical study titled "Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg". 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.

What is the current status of trial NCT00648921?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2003-06. Estimated completion is 2003-07.

What interventions are being tested in trial NCT00648921?

The interventions under investigation include: Olanzapine Tablets 5 mg (DRUG), Zyprexa® Tablets 5 mg (DRUG).

Who is sponsoring clinical trial NCT00648921?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.