Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Buprenorphine · 1 trial · 1 indication
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Buprenorphine 8 mg Sublingual Tablets |
| Reference Listed Drug | ACTIVE_COMPARATOR | Subutex® 8 mg Sublingual Tablets |
| Name | Type | Description |
|---|---|---|
| Buprenorphine | DRUG | 8 mg Sublingual Tablets |
Inclusion Criteria: * Subject must be a male or non-pregnant, non-breastfeeding female. * Subject must be between 18 and 45 years of age (inclusive). * Subject's Body Mass Index (BMI) must be between 18 and 30 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs). * Female subjects must ...