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Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers

NCT ID: NCT02183675

Last Updated: 2016-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T/A/H

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Group Type EXPERIMENTAL

Telmisartan/Amlodipine/HCTZ

Intervention Type DRUG

Telmisartan/Amlodipine/HCTZ fixed-dose combination

T/A

Telmisartan/Amlodipine fixed-dose combination

Group Type ACTIVE_COMPARATOR

Telmisartan/Amlodipine

Intervention Type DRUG

Telmisartan/Amlodipine fixed-dose combination

T/H

Telmisartan/HCTZ fixed-dose combination

Group Type ACTIVE_COMPARATOR

Telmisartan/HCTZ

Intervention Type DRUG

Telmisartan/HCTZ fixed-dose combination

Interventions

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Telmisartan/Amlodipine

Telmisartan/Amlodipine fixed-dose combination

Intervention Type DRUG

Telmisartan/Amlodipine/HCTZ

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Intervention Type DRUG

Telmisartan/HCTZ

Telmisartan/HCTZ fixed-dose combination

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1348.5.001 Boehringer Ingelheim Investigational Site

Kanagawa , Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1348.5

Identifier Type: -

Identifier Source: org_study_id