Text Size

Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01161667
First received: July 12, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention
Migraine
 Drug: naratriptan hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Migraine
U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: naratriptan hydrochloride
    2.5 mg tablet
    Other Name: AMERGE
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naratriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013