NCT05145608

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Single Dose Two Way Crossover Comparative Bioavailability Study of Lamotrigine Extended-Release Tablets USP 50 mg in Healthy Male and Female Volunteers Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Alembic Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Design: Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design Subjects: Twenty-two (22) subjects will be included in the study. Main Inclusion Criteria: Male and female volunteers, non- or ex-smokers, of at least 18 years of age to 54 years of age, inclusively, with a body mass index (BMI) within 22.00 to 30.00 kg/m2, inclusively, with a minimum body weight of 60 kg, will be selected according to the inclusion and exclusion criteria. Blood Sampling: In each study period, 23 blood samples will be collected. The first blood sample will be collected prior to drug administration while the others will be collected up to 192 hours after the drug administration. Wash-out: The drug administrations will be separated by at least 28 calendar days. Tests during study: An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as prior to discharge for each period of the study. For female subjects, a serum pregnancy test will be performed before each period of the study. Vital signs will be measured prior to and approximately 2, 4, 8, 10, 12, 24, 36 and 48 hours following each drug administration. Neurological function tests will be performed approximately 30 hours after each drug administration. For safety reasons, hematology tests will be performed before the 2nd period of the study. Post study Tests: Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study. A complete physical examination (including vital signs) will also be performed. Bioanalysis: Lamotrigine plasma concentrations will be measured by a validated bioanalytical method.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-10
• Primary completion: 2018-02-21
• Completion: 2018-02-21
• First posted: 2021-12-06
• Last updated: 2021-12-07

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study