Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamictal · 1 trial · 1 indication
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...
Lamictal is a small molecule drug being studied in healthy adults. It is currently in Phase 1 clinical development as an investigational product. The drug is being evaluated in a bioequivalence study comparing two formulations of lamotrigine 100 mg tablets.
Lamictal is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is conducting clinical trials to evaluate the drug's bioequivalence in healthy adult volunteers.
Lamictal is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
Lamictal has one completed clinical trial, NCT03898011, which was a bioequivalence study of two formulations of lamotrigine 100 mg tablets compared to Lamictal 100 mg tablets in healthy adult volunteers under fasting conditions. The trial enrolled 28 participants in Russia.
Lamictal is a brand name for the drug lamotrigine. The clinical trial NCT03898011 compares two formulations of lamotrigine 100 mg tablets to Lamictal 100 mg tablets, indicating that Lamictal contains the active ingredient lamotrigine.