Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamictal · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lamotrigine Tablets 200 mg | EXPERIMENTAL | Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited |
| Lamictal® 200 mg Tablets | ACTIVE_COMPARATOR | Lamictal® 200 mg Tablets of GlaxoSmithKline Inc |
| Name | Type | Description |
|---|---|---|
| Lamotrigine | DRUG | Lamotrigine Tablets 200 mg |
| Lamictal® | DRUG | Lamictal® 200 mg Tablets |
Inclusion Criteria: 1. Healthy males and females at least 18 years of age inclusive 2. Informed of the nature of the study and given written informed consent 3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 l...
Lamictal is being studied in healthy volunteers in Phase 1 bioequivalence trials. It is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. The trials are designed to compare the absorption of Lamotrigine Tablets 200 mg under fed and fasting conditions.
Lamictal is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is conducting Phase 1 bioequivalence studies for Lamotrigine Tablets 200 mg in healthy volunteers in the United States.
Lamictal is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, each enrolling 20 healthy volunteers. The drug is investigational and not yet approved for any indication.
Lamictal has two completed Phase 1 trials: NCT01513681, a bioequivalence study under fed conditions, and NCT01513720, a bioequivalence study under fasting conditions. Both enrolled 20 healthy volunteers in the United States and were active-controlled, randomized studies.
Yes, Lamictal is the brand name for lamotrigine. The clinical trials listed for Lamictal are specifically for Lamotrigine Tablets 200 mg, testing bioequivalence under fed and fasting conditions in healthy volunteers.