Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxybutynin Chloride · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Oxybutynin Chloride Extended-release Tablets 5 mg |
| 2 | ACTIVE_COMPARATOR | Ditropan XL® Tablets 5 mg |
| Name | Type | Description |
|---|---|---|
| Oxybutynin Chloride Extended-release Tablets 5 mg | DRUG | 4x5mg, single dose fed |
| Ditropan XL® Tablets 5 mg | DRUG | 4x5mg, 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 HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administra...
Oxybutynin Chloride is an investigational small molecule being studied in healthy volunteers. It is being developed by Viatris Inc. (VTRS) and is currently in Phase 1 clinical development. The drug is being evaluated in pharmacokinetic studies comparing extended-release tablets to a reference product.
Oxybutynin Chloride is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy adult volunteers.
Oxybutynin Chloride is in Phase 1 clinical development. Two Phase 1 studies have been completed, with a total of 88 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.
Oxybutynin Chloride has two completed Phase 1 trials: NCT00648843, a food study of extended-release tablets 5 mg versus Ditropan XL 5 mg with 28 participants, and NCT00650481, a fasting study with 60 participants. Both were conducted in the United States with healthy volunteers aged 18 and older.
Oxybutynin Chloride is being studied as a potential generic version of Ditropan XL. The clinical trials compare Oxybutynin Chloride extended-release tablets 5 mg directly against Ditropan XL tablets 5 mg to assess bioequivalence under fed and fasting conditions.