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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00829673 | Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2004 | Jun 1, 2004 | Aug 19, 2024 | 1 | United States |
| NCT00829712 | Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2004 | Jun 1, 2004 | Aug 19, 2024 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | Focalin® |
| Name | Type | Description |
|---|---|---|
| Dexmethylphenidate Hydrochloride | DRUG | 10 mg Tablet |
Inclusion Criteria 1. Sex: Male and Female; similar proportion of each preferred. 2. Age: At least 18 years. 3. Weight: BMI (Body Mass Index) less than or equal to 30. 4. Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examinatio...