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Also known as Paroxetine 12.5 milligrams tablet
Paroxetine 12.5 milligrams · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment sequence A/B/C | EXPERIMENTAL | Eligible subjects will be randomized in sequence A/B/C and will receive A: single tablet of paroxetine 12.5 milligrams, B: single tablet of paroxetine 25 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Treatment sequence A/C/B | EXPERIMENTAL | Eligible subjects will be randomized in sequence A/C/B and will receive A: single tablet of paroxetine 12.5 milligrams, C: two tablets of paroxetine 25 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Treatment sequence B/A/C | EXPERIMENTAL | Eligible subjects will be randomized in sequence B/A/C and will receive B: single tablet of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Treatment sequence B/C/A | EXPERIMENTAL | Eligible subjects will be randomized in sequence B/C/A and will receive B: single tablet of paroxetine 25 milligrams, C: two tablets of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Treatment sequence C/A/B | EXPERIMENTAL | Eligible subjects will be randomized in sequence C/A/B and will receive C: two tablets of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Treatment sequence C/B/A | EXPERIMENTAL | Eligible subjects will be randomized in sequence C/B/A and will receive C: two tablets of paroxetine 25 milligrams, B: single tablet of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period. |
| Name | Type | Description |
|---|---|---|
| Paroxetine 12.5 milligrams tablet | DRUG | Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally. |
| Paroxetine 25 milligrams tablet | DRUG | Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally. |
| Paroxetine 50 milligrams tablet | DRUG | Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally. |
Inclusion Criteria: * Healthy Japanese adult males between 20 and 64 years of age inclusive * BMI 18.50 or higher and \< 25.00 kg/m2, and bodyweight 50 kg or higher * Non-smokers * AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range * QTc(B) interval \<450 msec * ...
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Paroxetine 12.5 milligrams is a small molecule formulation of paroxetine developed by GSK plc. It is being studied as a controlled-release tablet for depressive disorder. The 12.5 milligram strength refers to the specific dose evaluated in clinical testing. It is an investigational product and is not described as approved.
Paroxetine 12.5 milligrams is being developed for depressive disorder. The clinical program has focused on this psychiatric indication. It is a controlled-release tablet formulation. The drug remains investigational and is not described as approved for any use.
Paroxetine 12.5 milligrams targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 inhibition is the mechanism associated with paroxetine. The drug is a small molecule developed for depressive disorder.
GSK plc, which trades under the ticker GSK, is the developer of Paroxetine 12.5 milligrams. The company is responsible for the clinical development of this controlled-release paroxetine tablet for depressive disorder.
Paroxetine 12.5 milligrams is in Phase 1 development. The program includes one completed Phase 1 trial. No active trials are listed. The drug is investigational and is not described as FDA approved.
Paroxetine 12.5 milligrams has been evaluated in one completed Phase 1 trial, NCT00938184, titled Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects. The trial enrolled 18 healthy male volunteers in Japan, was randomized and controlled, and is now completed.
Yes, Paroxetine 12.5 milligrams tablet is another name for Paroxetine 12.5 milligrams. Both refer to the same controlled-release paroxetine product developed by GSK plc for depressive disorder.