Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexmethylphenidate · 2 trials · 1 indication
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...
Dexmethylphenidate is a small molecule being studied in healthy volunteers. It is in Phase 1 clinical development by Teva Pharmaceutical Industries Limited. The drug is being evaluated in pharmacokinetic studies under fasting and non-fasting conditions to assess its absorption and bioavailability.
Dexmethylphenidate is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers in the United States.
Dexmethylphenidate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy adult volunteers.
Dexmethylphenidate has two completed Phase 1 trials: NCT00829673, a study of dexmethylphenidate hydrochloride tablets under non-fasting conditions, and NCT00829712, a study under fasting conditions. Each trial enrolled 24 healthy adults in the United States.
Dexmethylphenidate is the active ingredient, and the clinical trials studied dexmethylphenidate hydrochloride tablets. The hydrochloride salt form is used in the oral tablet formulation being tested in the Phase 1 trials.