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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01513720 | Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2002 | Dec 1, 2002 | Jan 20, 2012 | 1 | United States |
| NCT01513681 | Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition | PHASE1 | COMPLETED | 20 | — | — | Nov 1, 2002 | Nov 1, 2002 | Jan 20, 2012 | 1 | United States |
| 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...