PET measurement of hepatobiliary transport of Telmisartan in a therapeutic dose using [11C]Telmisartan in normal subjects as a determinant of nonlinear pharmacokinetics.

Phase 1

• Conditions: Healthy male subjects

• Registration Number: JPRN-UMIN000007715
• Lead Sponsor: Foundation for Biomedical Research and Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-10
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

1. Renal artery stenosis, bilaterally or unilaterally after nephrectomy 2. Hyperkalemia 3. Liver or renal dysfunction 4. Cerebrovascular disorders 5. Hypotension 6. Severe bradycardia, or WPW or LGL syndrome by ECG 7. Medication or dietary supplement including St. John's wort within 7 days prior to PET study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration time course and hepatobiliary pharmacokinetics of [11C]telmisartan.