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Completed

NCT Number: NCT01161667

Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles River Northwest Kinetics

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naratriptan hydrochloride

Drug

2.5 mg tablet

Other names: AMERGE

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fasted Conditions

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 13, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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