Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamotrigine Dispersible/Chewable · 2 trials · 1 indication
AUC(0-inf) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-inf) is defined as area under the concentration vs. time curve from zero to infinity.
AUC(0-t) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-t) is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
| Arm | Type | Description |
|---|---|---|
| Lamotrigine Dispersable/Chewable | EXPERIMENTAL | lamotrigine dispersible/chewable tablet 100mg |
| Lamotrigine Compressed | EXPERIMENTAL | lamotrigine compressed tablet 100mg |
| Lamotrigine (Lamictal) D/C 5mg*5, Crossover | EXPERIMENTAL | Single dose of lamotrigine dispersible/chewable (D/C)5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15 |
| Lamotrigine (Lamictal) Compressed 25mg, Crossover | EXPERIMENTAL | Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15 |
| Name | Type | Description |
|---|---|---|
| Lamotrigine Dispersible/Chewable tablet | DRUG | Single dose of lamotrigine dispersible/chewable 100mg tablet at Day1 |
| Lamotrigine Compressed tablet | DRUG | Single dose of lamotrigine compressed 100mg tablet at Day1 |
| Lamotrigine Dispersible/Chewable tablets 5mg*5 | DRUG | Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15 |
| Lamotrigine Compressed tablet 25mg | DRUG | Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15 |
Inclusion Criteria: * Healthy Chinese male non-smoker, based on medical history and physical examination, aged between 18 and 45 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation inc...