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Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use

NCT ID: NCT02121535

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

2014-04-30

Study Completion Date

2014-08-31

Brief Summary

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The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.

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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

A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet

Group Type EXPERIMENTAL

T80/A5 mg FDC tablet

Intervention Type DRUG

H12.5 mg tablet

Intervention Type DRUG

T80/A5/H12.5 mg FDC tablet

Intervention Type DRUG

T80/A5 mg FDC+H12.5 mg mono

A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet

Group Type ACTIVE_COMPARATOR

T80/A5 mg FDC tablet

Intervention Type DRUG

A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet

T80/A5/H12.5 ng FDC tablet

Intervention Type DRUG

A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet

H12.5 mf tablet

Intervention Type DRUG

A HCTZ 12.5 mg tablet

Interventions

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T80/A5 mg FDC tablet

Intervention Type DRUG

T80/A5 mg FDC tablet

A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet

Intervention Type DRUG

H12.5 mg tablet

Intervention Type DRUG

T80/A5/H12.5 ng FDC tablet

A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet

Intervention Type DRUG

H12.5 mf tablet

A HCTZ 12.5 mg tablet

Intervention Type DRUG

T80/A5/H12.5 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), 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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Boehringer Ingelheim Investigational Site

Kanagawa, Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1348.3

Identifier Type: -

Identifier Source: org_study_id

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