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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00730197 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Mylan Pharmaceuticals

146 total trials

What the finished NCT00730197 record still lists

NCT00730197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

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

NCT00730197 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00730197's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00730197, the US trial registry maintained by the National Library of Medicine. NCT00730197 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.