Trials / Completed
CompletedNCT01354418
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
A Randomized Crossover Bioequivalence Study Comparing a Single Dose of Phenylephrine HCl 30 mg Extended Release Tablet to Three Phenylephrine HCl 10 mg Immediate Release Tablets Each Consecutively Dosed Four Hours Apart Under Fed and Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Phenylephrine HCl Extended Release | One phenylephrine HCl 30 mg extended release tablet orally |
| DRUG | Phenylephrine HCl Immediate Release | One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2011-06-01
- Completion
- 2011-07-01
- First posted
- 2011-05-16
- Last updated
- 2015-02-23
Source: ClinicalTrials.gov record NCT01354418. Inclusion in this directory is not an endorsement.