DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 t

Area 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


Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017