Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161654
• Other study ID #: NARA-T25-PVFD-1
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: January 19, 2018
• Start date: August 2007
• Est. completion date: September 2007

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• naratriptan hydrochoride
2.5 mg tablet

Locations

Country	Name	City	State
United States	Charles River Northwest Kinetics	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		9 days