Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions

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

Tracking Information

• First Submitted Date: June 6, 2008
• First Posted Date: June 10, 2008
• Last Update Posted Date: January 23, 2018
• Study Start Date: February 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 9, 2008): Bioequivalence
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
• Official Title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Short Term Treatment of Insomnia

Intervention

Drug: Zaleplon

Short term treatment of insomnia

Other Name: Sonata

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2008): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00694317
• Other Study ID Numbers: ZALE-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Elizabeth Ernst, Director, DRA-MA, Roxane Laboratories, Inc,
• Original Responsible Party: Same as current
• Current Study Sponsor: Roxane Laboratories
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: So Ran Hong, M.D.; Novum Pharmaceutical Research Services

• PRS Account: West-Ward Pharmaceutical
• Verification Date: January 2018