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Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00694317
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Study Description
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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

Condition or disease Intervention/treatment Phase
Short Term Treatment of Insomnia Drug: Zaleplon Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Fed Conditions.
Study Start Date : February 2004
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Zaleplon

Arms and Interventions
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Intervention Details:
  • Drug: Zaleplon
    Short term treatment of insomnia
    Other Name: Sonata

Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694317


Locations
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United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Investigators
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Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
More Information
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Responsible Party: Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc,
ClinicalTrials.gov Identifier: NCT00694317    
Other Study ID Numbers: ZALE-02
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Zaleplon
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action