Bioequivalence study of LAMOTRIGINE 100mg tablet of Amin Pharm. Co., IRA

Not Applicable

Recruiting

• Conditions: Epilepsy.; Adverse effect of other antiepileptic and sedative-hypnotic drugs, initial encounter; T42.6X5A

• Registration Number: IRCT20190706044111N34
• Lead Sponsor: Amin Pharm. Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Aged between 18 - 50 years
- Body weight between 50 – 100 kg
- Having good health on the basis of medical history and physical & clinical examination
- Understand the procedures and give written informed consent

Exclusion Criteria

Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of lamotrigine. Timepoint: At 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24.0, 48.0 & 72.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography wit UV detector (HPLC/UV).