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An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration
The purpose of this study is to: To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces
Details
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 4 |
| Start date | 2008-09 |
| Completion | 2008-10 |
Conditions
- Hypertension
- Congestive Heart Failure
Interventions
- BIA-5-453
Primary outcomes
- urinary excretion of BIA 5-453 associated radioactivity — pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
following a single 600 mg oral dose labeled with 98 μCi of \[14C\] - faecal excretion of BIA 5-453 associated radioactivity — following a single 600 mg oral dose labeled with 98 μCi of [14C]
baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period. - amount of BIA 5-453 associated radioactivity present in the expired air — baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose
following a single 600 mg oral dose labeled with 98 μCi of \[14C\]
Countries
Switzerland