Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg

ClinicalTrials.gov ID: NCT00985660

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Official title

Single-Dose Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets (30 mg; Mylan) and Sular® Extended Release Tablets (30 mg; First Horizon) 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 nisoldipine extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg tablet) dose administration in healthy adult subjects under fasting conditions.

Study identification

NCT ID: NCT00985660
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Mylan Pharmaceuticals Inc; Industry
Enrollment: 78 participants

Conditions and interventions

Conditions

Healthy

Interventions

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: Jun 2007 (Type not available)
Primary completion: Jul 2007 (Actual)
Completion: Jul 2007 (Actual)
Last update posted: Sep 28, 2009

2007

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 NCT00985660, 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 Sep 28, 2009 · Synced Nov 12, 2026