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Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use

NCT ID: NCT02129192

Last Updated: 2017-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).

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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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T80/A5/H12.5 mg FDC

Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet

Group Type EXPERIMENTAL

T80/A5/H12.5 mg FDC tablet

Intervention Type DRUG

Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet

T80/H12.5 FDC + A5 mono

Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule

Group Type ACTIVE_COMPARATOR

Amlodipine 5mg capsule

Intervention Type DRUG

Amlodipine 5mg capsule

T80/H12.5 mg FDC tablet

Intervention Type DRUG

Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet

Interventions

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Amlodipine 5mg capsule

Amlodipine 5mg capsule

Intervention Type DRUG

T80/H12.5 mg FDC tablet

Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet

Intervention Type DRUG

T80/A5/H12.5 mg FDC tablet

Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy 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)
* 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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Boehringer Ingelheim Investigational Site

Tokyo, Hachioji, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1348.4

Identifier Type: -

Identifier Source: org_study_id

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