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

A randomized, open label, two treatments, two periods, two sequences, single dose, crossover, bioequivalence study of Lamotrigine 100mg tablet of Amin Pharm. Co., IRAN in comparison of LAMICTAL 100mg tablet of GSK in 24 healthy adult subjects under fasting condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N34

Enrollment

Registered

2023-12-23

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Adverse effect of other antiepileptic and sedative-hypnotic drugs, initial encounter

Interventions

Intervention 1: Intervention group: LAMOTRIGINE 100mg oral tablet of Amin Pharm. Co., (IRAN), single dose in fasting condition. Intervention 2: Control group: LAMICTAL 100mg oral tablet, produced by G

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026