Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JZoloft · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| JZoloft | ACTIVE_COMPARATOR | Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions |
| ODT without water | EXPERIMENTAL | sertraline ODT 50 mg without water as a single oral dose under fasted conditions |
| ODT with water | EXPERIMENTAL | sertraline ODT 50 mg with water as a single oral dose under fasted conditions |
| Name | Type | Description |
|---|---|---|
| JZoloft | DRUG | 50 mg tablet on Day 1 of each period |
| sertraline ODT | DRUG | 50 mg tablet on Day 1 of each period |
Inclusion Criteria: * Healthy Japanese subjects between the ages of 20 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious ...
JZoloft is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE). It is being studied in healthy volunteers, and it is currently in Phase 1 clinical development. JZoloft is not approved by the FDA and remains in clinical testing.
JZoloft is being studied for use in healthy subjects, specifically to assess bioequivalence. The ongoing clinical development focuses on healthy Japanese participants, and the drug is not intended for a specific disease indication at this stage.
JZoloft is developed by Pfizer, Inc., a global biopharmaceutical company. Pfizer is publicly traded on the New York Stock Exchange under the ticker symbol PFE.
JZoloft is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still in the early stages of clinical testing.
JZoloft has one completed Phase 1 trial, NCT01699724, titled "Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects." The trial enrolled 30 healthy participants in Japan and was active-controlled, though it is no longer active.
JZoloft is being studied for bioequivalence to Zoloft ODT, meaning it is intended to be a comparable formulation. The trial compares the two, but JZoloft is a distinct investigational product developed by Pfizer.