Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Short Term Treatment of Insomnia
Intervention: Zaleplon (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
So Ran Hong, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
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
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions.
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Novum Pharmaceutical Research Services, Houston, Texas 77042, United States
Additional Information
Starting date: January 2004
Ending date: February 2004
Last updated: June 9, 2008
|
