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Completed Phase 1 Interventional Accepts healthy volunteers

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

ClinicalTrials.gov ID: NCT00649376

Public ClinicalTrials.gov record NCT00649376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Single-Dose Fasting In Vivo Bioequivalence Study of Fexofenadine Tablets (180 mg; Mylan) and Allegra® Tablets (180 mg; Aventis) in Healthy Adult Volunteers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.

Study identification

NCT ID
NCT00649376
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Mylan Pharmaceuticals Inc
Industry
Enrollment
68 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2003
Primary completion
Oct 31, 2003
Completion
Oct 31, 2003
Last update posted
Apr 23, 2024

2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Kendle International Inc. Morgantown West Virginia 26505

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00649376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2024 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00649376 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →