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AN OPEN-LABEL STUDY IN HEALTHY MALE SUBJECTS TO ASSESS THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-LABELED BIA 9-1067 AND METABOLITES FOLLOWING A SINGLE-DOSE ORAL ADMINISTRATION

AN OPEN-LABEL STUDY IN HEALTHY MALE SUBJECTS TO ASSESS THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-LABELED BIA 9-1067 AND METABOLITES FOLLOWING A SINGLE-DOSE ORAL ADMINISTRATION - BIA 9-1067 ADME study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35986
Enrollment
6
Registered
2011-03-15
Start date
2011-03-25
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Active stubstance: BIA 9-1067 and [14C] BIA 9-1067

Sponsors

Bial Portela & Ca.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects Age: 18-55 years BMI: 18.0 - 30.0 kg/m2

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1 liter of blood in the 10 months prior the start of this study.

Design outcomes

Primary

MeasureTime frame
- Radiokinetics - Pharmacokinetics

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)