Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

This study has been completed.

First Received: June 6, 2008 Last Updated: June 9, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00694187

Purpose

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

Condition	Intervention
Short Term Treatment of Insomnia	Drug: Zaleplon

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions.

Resource links provided by NLM:

Drug Information available for: Zaleplon

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two Period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	January 2004
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694187

Locations

United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

So Ran Hong, M.D.

Novum Pharmaceutical Research Services

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, DRA-MA )
Study ID Numbers:	ZALE-01
Study First Received:	June 6, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00694187 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Zaleplon
Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives

Central Nervous System Depressants
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009