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An Open-Label Study to Determine the ADME of 14C-labeled SLV337 after a Single Dose of an Oral Suspension

An Open-Label Study to Determine the ADME of 14C-labeled SLV337 after a Single Dose of an Oral Suspension - SLV337 ADME study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34267
Enrollment
12
Registered
2010-07-06
Start date
2010-07-15
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

diabetes Type 2 diabetes mellitus

Interventions

Active substance: SLV337 and [14C]-SLV337

Sponsors

Laboratoires Fournier S.A.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male - 18 - 55 years of age, inclusive - BMI 18.0 - 28.0 kg/m2 (50 - 100 kg) - Non-smoker

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 12 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 12 months prior to the start of this study.

Design outcomes

Primary

MeasureTime frame
Radiodynamics Pharmacokinetics Safety

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)