Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

Roxane Laboratories35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine

Interventions

naratriptan hydrochlorideDRUG

2.5 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Charles River Northwest Kinetics

Tacoma, Washington, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 9 days

Data from ClinicalTrials.gov

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