Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension and Dyslipidemia

Treatments: Drug: Telmisartan; Drug: Rosuvastatin; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02933658

DW-1501-P101

Details and patient eligibility

About

A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Enrollment: 71 patients

Sex: Male

Ages: 19 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male who are ≥19, <50 years old
• Man who weights over 55kg and whose BMI is 18~30(kg/m2)
• Man who doesn't have any chronic disease or history of disease

Exclusion criteria

• man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Reference1

Experimental group

Description:

single(Reference1) -\> combination(Reference1+Reference2)

Treatment:

Drug: Rosuvastatin

Drug: Telmisartan

Drug: Amlodipine

Reference2

Experimental group

Description:

single(Reference2) -\> combination(Reference1+Reference2)

Treatment:

Drug: Rosuvastatin

Drug: Telmisartan

Drug: Amlodipine