Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Paroxetine Controlled Release Tablet, Paroxetine controlled release tablet
Paroxetine Controlled Release · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving paroxetine | EXPERIMENTAL | Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days. |
| Subjects receiving treatment sequence ABC | EXPERIMENTAL | Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days. |
| Subjects receiving treatment sequence BAC | EXPERIMENTAL | Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days. |
| Subjects receiving treatment sequence CBA | EXPERIMENTAL | Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days. |
| Subjects receiving treatment sequence BCA | EXPERIMENTAL | Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days. |
| Subjects receiving treatment sequence CAB | EXPERIMENTAL | Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days. |
| Subjects receiving treatment sequence ACB | EXPERIMENTAL | Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days. |
| Name | Type | Description |
|---|---|---|
| Paroxetine Controlled Release Tablet | DRUG | Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams. |
Inclusion criteria: * 19-45 years healthy Chinese subjects * Body weight \> 50 kg * BMI between 19-25 * serological negative for HIV, syphilis and hepatitis B and C * no abnormalities in ECG * Female with negative pregnancy and male has no plan to have a child during and 3 months after the study. ...
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