NCT01161667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

July 12, 2010

Last Update Submit

January 19, 2018

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    9 days

Interventions

naratriptan hydrochlorideDRUG

2.5 mg tablet

Also known as: AMERGE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles River Northwest Kinetics

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

naratriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Linda Bavisotto, M.D.

    Charles River Northwest Kinetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 13, 2010

Study Start

September 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)