---
title: Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions
nct_id: NCT01161667
overall_status: COMPLETED
phase: NA
sponsor: Roxane Laboratories
study_type: INTERVENTIONAL
primary_condition: Migraine
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01161667.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01161667"
ct_last_update_post_date: 2018-01-23
last_seen_at: "2026-05-12T07:18:30.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

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

**NCT ID:** [NCT01161667](https://clinicaltrials.gov/study/NCT01161667)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 35
- **Lead Sponsor:** Roxane Laboratories
- **Conditions:** Migraine
- **Start Date:** 2007-09
- **Completion Date:** 2007-09
- **CT.gov Last Update:** 2018-01-23

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Interventions

- **naratriptan hydrochloride** (DRUG) — 2.5 mg tablet

## Primary Outcomes

- **bioequivalence determined by statistical comparison Cmax** _(time frame: 9 days)_

## Locations (1)

- Charles River Northwest Kinetics, Tacoma, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.charles river northwest kinetics|tacoma|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01161667.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01161667*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*