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Ditropan XL · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Oxybutynin Chloride Extended-Release Tablets, 15 mg |
| 2 | ACTIVE_COMPARATOR | Ditropan XL® Extended-release tablets, 15 mg |
| Name | Type | Description |
|---|---|---|
| Oxybutynin Chloride Extended-Release Tablets, 15 mg | DRUG | 15mg, single dose fasting |
| Ditropan XL® Extended-release tablets, 15 mg | DRUG | 15mg, single dose fasting |
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 a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to the start of the study and on the even...
Ditropan XL is an extended-release formulation of oxybutynin chloride, a small molecule used in a clinical study involving healthy volunteers. The study was designed to compare the fasting pharmacokinetics of Ditropan XL 15 mg tablets with a generic version. It is not approved for any specific disease indication based on the available data.
Ditropan XL is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company conducted a Phase 1 clinical trial to evaluate the drug's pharmacokinetic profile in healthy subjects.
Ditropan XL is in Phase 1 clinical development. The only registered trial for this drug is a Phase 1 fasting study that has been completed. As an investigational drug, it is still in early-stage clinical testing and has not been approved by regulatory authorities.
Ditropan XL has one completed Phase 1 clinical trial registered under NCT00649272, titled "Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg." The study enrolled 80 healthy adult participants in the United States and was active-controlled but not double-blinded.
Ditropan XL is a brand-name extended-release formulation of oxybutynin chloride. The clinical trial compared Ditropan XL 15 mg tablets to a generic oxybutynin chloride extended-release tablet to assess bioequivalence under fasting conditions. Both contain the same active ingredient, oxybutynin chloride.