Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg

Phase 1CompletedNCT02011633

Hanmi Pharmaceutical Company Limited72 enrolled

Overview

To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

HCP1201 500/10mgDRUG

500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Metformin SR 500mgDRUG

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Rosuvastatin 10mgDRUG

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male volunteer, age 20\~55 years * The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2 * Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Exclusion Criteria: * Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study * History of relevant drug allergies or clinically significant hypersensitivity reaction.

Locations (1)

Samsung Medical Center

Seoul, South Korea