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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01183234 | SPD544 High Strength Bioequivalence Study | PHASE1 | COMPLETED | 28 | — | — | Aug 27, 2010 | Oct 22, 2010 | Jun 9, 2021 | 1 | United Kingdom |
AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
| Arm | Type | Description |
|---|---|---|
| SPD544 (Equasym XL) | EXPERIMENTAL | - |
| Methylphenidate hydrochloride (Metadate CD ) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SPD544 | DRUG | two 30mg capsules, single oral dose |
| Methylphenidate hydrochloride | DRUG | one 60mg capsule, single oral dose |
Inclusion criteria: 1. Healthy subjects, aged 18-55 years inclusive at the time of consent. 2. Subject must be willing to comply with applicable contraceptive requirements of the protocol and be: * Male, or * Non-pregnant, non-lactating female who must be \>90 days post-partum or nulliparous...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |