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COMPLETED Phase 1

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

NCT01513681 · View on ClinicalTrials.gov ↗

Study Summary

This is an single dose,two-way, crossover, oral bioequivalence study.

Conditions Studied

Interventions

  • DRUG Lamotrigine
  • DRUG Lamictal®

Study Locations (1)

North Carolina

  • AAI Clinic — Quadrangle Drive

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2002-11
Est. Completion 2002-11
Phase Phase 1

Sponsor

Dr. Reddy's Laboratories Limited

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01513681

The ClinicalTrials.gov registry entry for NCT01513681 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 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 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions — of which Lamotrigine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01513681 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01513681 about?

NCT01513681 is a clinical study titled "Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition". This is an single dose,two-way, crossover, oral bioequivalence study.

What is the current status of trial NCT01513681?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2002-11. Estimated completion is 2002-11.

What conditions does trial NCT01513681 study?

This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01513681?

The interventions under investigation include: Lamotrigine (DRUG), Lamictal® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01513681?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01513681 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial