Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg

ClinicalTrials.gov ID: NCT00648362

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Official title

Single-Dose Fasting In Vivo Bioequivalence Study of Glimepiride Tablets (1 mg; Mylan) to Amaryl® Tablets (1 mg; Aventis) in Healthy 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 glimepiride 1 mg tablets to Aventis Amaryl® 1 mg tablets following a single, oral 1 mg (1 x 1 mg) dose administered under fasting conditions.

Study identification

NCT ID: NCT00648362
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Mylan Pharmaceuticals Inc; Industry
Enrollment: 40 participants

Conditions and interventions

Conditions

Healthy

Interventions

Glimepiride Tablets 1 mg Drug
Amaryl® Tablets 1 mg Drug

Drug

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: Nov 2004 (Type not available)
Primary completion: Nov 2004 (Actual)
Completion: Dec 2004 (Actual)
Last update posted: Apr 24, 2024

2004

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
PRACS Institute, Ltd.	Fargo	North Dakota	58104	—

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 NCT00648362, 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 24, 2024 · Synced Nov 12, 2026