Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions - Tabular View

Tracking Information

First Received Date ^ICMJE

June 6, 2008

Last Updated Date

June 9, 2008

Start Date ^ICMJE

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00694317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

Official Title ^ICMJE

A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Short Term Treatment of Insomnia

Intervention ^ICMJE

Drug: Zaleplon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to Zaleplon or any comparable or similar product.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00694317

Responsible Party

Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc,

Study ID Numbers ^ICMJE

ZALE-02

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

So Ran Hong, M.D.

Novum Pharmaceutical Research Services

Information Provided By

Roxane Laboratories

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP