A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP0912 / Irbesartan and Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447797

HM-IBAT-104

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912

Enrollment: 52 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20 and 45
• Signed informed consent form
• weight : over 45kg and in the range of ±20% of IBW

Exclusion criteria

• Has a medical history of hypersensitivity to atorvastatin or irbesartan
• severe Hypotension
• Not eligible for subject in health examination within 28 days of IP administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

HCP0912

Experimental group

Description:

Irbesartan/Atorvastatin combination tablet

Treatment:

Drug: HCP0912 / Irbesartan and Atorvastatin

Irbesartan and Atorvastatin

Active Comparator group

Description:

coadministration of irbesartan and atorvastatin

Treatment:

Drug: HCP0912 / Irbesartan and Atorvastatin