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Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01161654
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 13, 2010
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE August 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2010)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01161654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions
Official Title  ICMJE A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fed Conditions
Brief Summary The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fed conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: naratriptan hydrochoride
2.5 mg tablet
Other Name: AMERGE
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2010)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 naratriptan hydrochloride or any comparable or similar product.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01161654
Other Study ID Numbers  ICMJE NARA-T25-PVFD-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Ernst, Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
Study Sponsor  ICMJE Roxane Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Bavisotto, M.D. Charles River Northwestern Kinetics
PRS Account West-Ward Pharmaceutical
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP