Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Telmisartan/Amlodipine (Drug); Telmisartan/Amlodipine/HCTZ (Drug); Telmisartan/HCTZ (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
To assess drug drug interaction through pharmacokinetics investigation at steady state of
Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different
formulations in healthy Japanese male subjects
Clinical Details
Official title: Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum measured concentration (Cmax) of the analyte in plasma at steady state over the dosing interval tArea under the plasma concentration curve of the analyte in plasma at steady state over the dosing interval t
Secondary outcome: Amount of the analyte excreted in urine over the time interval from 0 to 24 hr at steady state
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
Inclusion criteria:
- Healthy Japanese male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80
kg; body mass index: >=18. 0 and <=25. 0 kg/m2
- Without any clinically significant findings and complications on the basis of a
complete medical history, including the physical examination, vital signs (blood
pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs),
clinical laboratory tests
- Signed and dated written informed consent prior to admission to the trial in
accordance with the Good Clinical Practice (GCP) and the local legislation.
Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal
and of clinical relevance.
Locations and Contacts
1348.5.001 Boehringer Ingelheim Investigational Site, Kanagawa , Yokohama, Japan
Additional Information
Starting date: July 2014
Last updated: November 6, 2014
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