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NCT01659931 · ClinicalTrials.gov registry record · Early Phase 1

Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

A Early Phase 1 study of Asthma, sponsored by Roxane Laboratories.

Completed
Registry status
Early Phase 1
Development phase
34
Enrollment target
1
Study location

NCT01659931 is a Early Phase 1 study of Asthma that has completed, run by Roxane Laboratories. The registered enrollment target is 34 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01659931, a Early Phase 1 study of Asthma, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
Early Phase 1
Development phase
34 participants
Enrollment target
1
Study location

Study Summary

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

Conditions Studied

Asthma

Interventions

  • DRUG Montelukast
  • DRUG Singulair

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2008-02
Est. Completion 2008-02
Phase Early Phase 1

Sponsor

Roxane Laboratories

93 total trials

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What the Registry Record Tells You About NCT01659931

The ClinicalTrials.gov registry entry for NCT01659931 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Montelukast is the first listed.

NCT01659931 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.

Frequently Asked Questions

What is clinical trial NCT01659931 about?

NCT01659931 is a clinical study titled "Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions". The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions

What is the current status of trial NCT01659931?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2008-02. Estimated completion is 2008-02.

What conditions does trial NCT01659931 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT01659931?

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

Who is sponsoring clinical trial NCT01659931?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01659931 being conducted?

This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.