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NCT01131975 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

A Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01131975 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 26 participants.

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The verdict

NCT01131975, a Phase 1 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

Interventions

  • DRUG Lamotrigine

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2003-01
Est. Completion 2003-03
Phase Phase 1

Sponsor

Dr. Reddy's Laboratories Limited

52 total trials

What the Registry Record Tells You About NCT01131975

The ClinicalTrials.gov registry entry for NCT01131975 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lamotrigine is the first listed.

NCT01131975 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01131975 about?

NCT01131975 is a clinical study titled "Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition". The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

What is the current status of trial NCT01131975?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2003-01. Estimated completion is 2003-03.

What interventions are being tested in trial NCT01131975?

The interventions under investigation include: Lamotrigine (DRUG).

Who is sponsoring clinical trial NCT01131975?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 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.