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NCT00730197 · ClinicalTrials.gov registry record · Phase 1

Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target

NCT00730197 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 48 participants.

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The verdict

NCT00730197, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fasting conditions.

Interventions

  • DRUG Albuterol Sulfate Extended-Release Tablets 8 mg
  • DRUG VoSpire® ER Tablets 8 mg

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2007-02
Est. Completion 2007-03
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00730197

The ClinicalTrials.gov registry entry for NCT00730197 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Albuterol Sulfate Extended-Release Tablets 8 mg is the first listed.

NCT00730197 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00730197 about?

NCT00730197 is a clinical study titled "Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg". The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy ...

What is the current status of trial NCT00730197?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2007-02. Estimated completion is 2007-03.

What interventions are being tested in trial NCT00730197?

The interventions under investigation include: Albuterol Sulfate Extended-Release Tablets 8 mg (DRUG), VoSpire® ER Tablets 8 mg (DRUG).

Who is sponsoring clinical trial NCT00730197?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.