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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

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Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: H12.5 mf tablet
Drug: H12.5 mg tablet
Drug: T80/A5 mg FDC tablet
Drug: T80/A5/H12.5 ng FDC tablet
Drug: T80/A5/H12.5 mg FDC tablet

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

72 participants in 2 patient groups

T80/A5/H12.5 mg FDC
Experimental group
Description:
A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet
Treatment:
Drug: T80/A5/H12.5 mg FDC tablet
Drug: T80/A5 mg FDC tablet
Drug: T80/A5 mg FDC tablet
Drug: H12.5 mg tablet
T80/A5 mg FDC+H12.5 mg mono
Active Comparator group
Description:
A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
Treatment:
Drug: T80/A5 mg FDC tablet
Drug: T80/A5 mg FDC tablet
Drug: T80/A5/H12.5 ng FDC tablet
Drug: H12.5 mf tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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