Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 72
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet arm 2: A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet

Interventions: intervention 1: T80/A5 mg FDC tablet intervention 2: T80/A5 mg FDC tablet intervention 3: H12.5 mg tablet intervention 4: T80/A5/H12.5 ng FDC tablet intervention 5: H12.5 mf tablet intervention 6: T80/A5/H12.5 mg FDC tablet
Intervention descriptions: intervention 1: None intervention 2: A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet intervention 3: None intervention 4: A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet intervention 5: A HCTZ 12.5 mg tablet intervention 6: None

Protocol document: