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NCT01659892 · ClinicalTrials.gov registry record · Early Phase 1

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

A Early Phase 1 study, sponsored by Roxane Laboratories.

Completed
Registry status
Early Phase 1
Development phase
36
Enrollment target

NCT01659892 is a Early Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 36 participants.

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The verdict

NCT01659892, a Early Phase 1 study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
Early Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions

Interventions

  • DRUG Montelukast
  • DRUG Singulair

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2008-08
Est. Completion 2008-08
Phase Early Phase 1

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT01659892

The ClinicalTrials.gov registry entry for NCT01659892 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Montelukast is the first listed.

NCT01659892 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01659892 about?

NCT01659892 is a clinical study titled "Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions". The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions

What is the current status of trial NCT01659892?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2008-08. Estimated completion is 2008-08.

What interventions are being tested in trial NCT01659892?

The interventions under investigation include: Montelukast (DRUG), Singulair (DRUG).

Who is sponsoring clinical trial NCT01659892?

This trial is sponsored by Roxane Laboratories, which has 93 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.