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Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00694187
First received: June 6, 2008
Last updated: June 9, 2008
Last verified: June 2008
  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: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Zaleplon
Anticonvulsants
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014