Trials / Completed
CompletedNCT01330472
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xanax XR tablets 3 mg (sourced from Caugus) | Tablets, 3 mg, single dose |
| DRUG | Xanax XR tablets 3 mg (sourced from Barceloneta) | Tablets, 3 mg, single dose |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2011-04-07
- Last updated
- 2021-01-28
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT01330472. Inclusion in this directory is not an endorsement.