Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: amosartan; Drug: amosartan and rosuvastatin; Drug: rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02140489

HM-ALRO-101

Details and patient eligibility

About

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

Enrollment: 30 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male
• Age between 19 and 55
• Signed informed consent

Exclusion criteria

• Presence of medical history or a concurrent disease
• Has a history of hypersensitivity to IP ingredients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Sequence 1

Experimental group

Description:

amosartan → rosuvastatin → amosartan and rosuvastatin

Treatment:

Drug: rosuvastatin

Drug: amosartan and rosuvastatin

Drug: amosartan

Sequence 2

Experimental group

Description:

rosuvastatin → amosartan and rosuvastatin → amosartan

Treatment:

Drug: rosuvastatin

Drug: amosartan and rosuvastatin

Drug: amosartan

Sequence 3

Experimental group

Description:

amosartan and rosuvastatin → amosartan → rosuvastatin

Treatment:

Drug: rosuvastatin

Drug: amosartan and rosuvastatin

Drug: amosartan