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Clinical Trials/NL-OMON38625
NL-OMON38625
Completed
Not Applicable

Assessment of pharmacokinetics and pharmacokinetic drug-drug interaction with ketoconazole of the metabolite S 41015 after single oral unlabelled microdoses of S 41015 and i.v. radiolabelled microdoses of [14C]-S 41015, and pharmacokinetics of S 38844 after single oral unlabelled microdose of S 38844 and i.v. radiolabelled microdose of [14C]-S 38844 in healthy male participants - S 41015 and S 38844 microdosing study

Institut de Recherches Internationales Servier I.R.I.S0 sites6 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
hart- en vaatziekten
Sponsor
Institut de Recherches Internationales Servier I.R.I.S
Enrollment
6
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Institut de Recherches Internationales Servier I.R.I.S

Eligibility Criteria

Inclusion Criteria

  • healthy male Caucasian subjects,
  • non\-smoking or smoking less then 5 cigarettes per day,
  • EM for CYP2C9,
  • 18 \- 45 yrs, inclusive,
  • 18\.5 \- 30\.0 kg/m2, inclusive

Exclusion Criteria

  • Suffering from hepatitis B, hepatitis C, 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 3 months from the start of the study.

Outcomes

Primary Outcomes

Not specified

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