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Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions

NCT04938856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-09-08

No results posted yet for this study

Summary

Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.

Conditions

  • Bioequivalence

Interventions

DRUG

Lamotrigine tablet

Lamotrigine 100 mg immediate release Tablet

Sponsors & Collaborators

  • The Searle Company LTD., Pakistan.

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Prof. Dr. Muhammad R Shah, PhD · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi

  • Dr. Naghma Hashmi (Co-PI), PhD · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2020-09-24
Completion
2020-10-25

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938856 on ClinicalTrials.gov