Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg

NCT ID: NCT02026817

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-01-31

Brief Summary

To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.

Detailed Description

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCP1201

Participants received a single oral dose of the HCP1201 750/10 mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Group Type: EXPERIMENTAL

HCP1201 750/10mg

Intervention Type: DRUG

750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Metformin and Rosuvastatin

Participants received a single oral dose of coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Group Type: ACTIVE_COMPARATOR

Metformin SR 750mg

Intervention Type: DRUG

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Rosuvastatin 10mg

Intervention Type: DRUG

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Interventions

HCP1201 750/10mg

750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Intervention Type: DRUG

Metformin SR 750mg

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Intervention Type: DRUG

Rosuvastatin 10mg

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Intervention Type: DRUG

Other Intervention Names

Glucophage SR 750 mg; Crestor 10mg

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung-Ryul Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-MERO-104

Identifier Type: -

Identifier Source: org_study_id