Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03898011 | A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Mar 23, 2019 | May 4, 2019 | Jun 6, 2019 | 1 | Russia |
Maximum concentration in plasma among observed concentrations at pre-specified time points
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
| Arm | Type | Description |
|---|---|---|
| Sequence Test-Reference (TR) | OTHER | 14 participants (total number of enrolled volunteers - 28) assigned to sequence TR will receive a single 100 mg dose of the test product Lamotrigine (1 x 100 mg tablet) marked as T in period 1 and a single 100 mg dose of the reference product Lamictal (1 x 100 mg tablet) marked as R in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence Reference-Test (RT) | OTHER | 14 participants (total number of enrolled volunteers - 28) assigned to sequence RT will receive a single 100 mg dose of the reference product Lamictal (1 x 100 mg tablet) marked as R in period 1 and a single 100 mg dose of the test product Lamotrigine (1 x 100 mg tablet) marked as T in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Lamotrigine | DRUG | Lamotrigine, 100 mg Tablets, manufactured by Pharmtechnology LLC, Belarus |
| Lamictal | DRUG | Lamictal®, 100 mg Tablets, marketed by GlaxoSmithKline Trading CJSC, Russia |
Inclusion Criteria: * Healthy caucasian men or women aged between 18 to 45 years * Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies * Body mass index 18.5-30 kg/m² with b...