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

NCT01131975 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT01131975 record still lists

NCT01131975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

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

NCT01131975 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01131975's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 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 NCT01131975, the US trial registry maintained by the National Library of Medicine. NCT01131975 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.