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Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

NCT05145608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-12-07

No results posted yet for this study

Summary

Objective:

To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions.

The secondary objective is to monitor the safety of the subjects.

Conditions

  • Bioequivalence

Interventions

DRUG

Lamotrigine ER tablet 50mg

In each study period, a single 50 mg dose of lamotrigine will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.

Sponsors & Collaborators

  • Alembic Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2018-02-21
Completion
2018-02-21
FDA Drug
Yes

Countries

  • Canada

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 NCT05145608 on ClinicalTrials.gov