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Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01161667
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fasted conditions.

Condition or disease Intervention/treatment Phase
Migraine Drug: naratriptan hydrochloride Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fasted Conditions
Study Start Date : September 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: naratriptan hydrochloride
    2.5 mg tablet
    Other Name: AMERGE


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ]


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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 naratriptan hydrochloride or any comparable or similar product.

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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): NCT01161667


Locations
United States, Washington
Charles River Northwest Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Linda Bavisotto, M.D. Charles River Northwest Kinetics

Responsible Party: Elizabeth Ernst, Cirector, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01161667     History of Changes
Other Study ID Numbers: NARA-T25-PVFS-1
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Naratriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs