Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedJanuary 23, 2018
January 1, 2018
Same day
June 6, 2008
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Bioequivalence
Interventions
Eligibility Criteria
You may qualify if:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novum Pharmaceutical Research Services
Houston, Texas, 77042, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
So Ran Hong, M.D.
Novum Pharmaceutical Research Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
February 1, 2004
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
January 23, 2018
Record last verified: 2018-01