Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zoloft · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sertraline Hydrochloride Tablets 100 mg |
| 2 | ACTIVE_COMPARATOR | Zoloft® Tablets 100 mg |
| Name | Type | Description |
|---|---|---|
| Sertraline Hydrochloride Tablets 100 mg | DRUG | 100mg, single dose fed |
| Zoloft® Tablets 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening...
Zoloft is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating its pharmacokinetics and food effects. The drug is being developed by Viatris Inc. and is not yet approved for any indication.
Zoloft is being developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to study the drug's properties in healthy subjects.
Zoloft is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Zoloft has two completed Phase 1 trials: NCT00648856, a food study of sertraline hydrochloride tablets 100 mg and Zoloft tablets 100 mg, and NCT00650325, a study of the same formulations. Both trials enrolled healthy adults in the United States.
Zoloft is a brand name for sertraline hydrochloride. The clinical trials for Zoloft compare the drug to sertraline hydrochloride tablets, indicating they are the same active ingredient. The studies evaluate the bioequivalence of the two formulations.