Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 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. ...
Top 20 of 31 competitors
Paroxetine Controlled Release is a small molecule antidepressant developed by GSK plc (ticker GSK) for depressive disorder. It is an investigational controlled release tablet formulation that has been studied in Phase 1 clinical trials. The program includes two completed pharmacokinetic studies conducted in healthy Chinese subjects.
Paroxetine Controlled Release is being developed for depressive disorder, within the psychiatry therapeutic area. Its clinical program consists of two completed Phase 1 pharmacokinetic trials in healthy volunteers, so it remains an investigational formulation rather than an approved product for this use.
Paroxetine Controlled Release targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 inhibition increases serotonin availability in the synaptic cleft, which is the mechanism underlying its development for depressive disorder.
GSK plc, which trades under the ticker GSK, is the developer of Paroxetine Controlled Release. The company sponsored the clinical program evaluating this controlled release tablet formulation for depressive disorder.
Paroxetine Controlled Release is in Phase 1 development. Both of its clinical trials are Phase 1 pharmacokinetic studies, and both are completed, with no active trials currently listed. It is an investigational product and is not described as approved.
Two completed Phase 1 trials have evaluated Paroxetine Controlled Release: NCT00406432, a repeat dose pharmacokinetic study in 12 healthy Chinese subjects, and NCT00406003, a single dose pharmacokinetic study of 12.5 to 37.5 mg in 6 healthy Chinese subjects. Both enrolled adults aged 19 years and older in China.
Yes. Paroxetine Controlled Release is also known as Paroxetine Controlled Release Tablet. These names refer to the same GSK product candidate, a controlled release tablet formulation of paroxetine being studied for depressive disorder.