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Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg

NCT ID: NCT01929512

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-08-31

Brief Summary

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To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and co-administration of metformin 750 mg plus rosuvastatin 20 mg under fasted and fed state, respectively.

Detailed Description

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An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/20 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 20 mg in Healthy Volunteers

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HCP1201, Part 1

Participants received a single oral dose of the HCP1201 750/20mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Group Type EXPERIMENTAL

HCP1201 750/20mg

Intervention Type DRUG

750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Metformin and Rosuvastatin, Part1

Participants received a single oral dose of coadministration of Metformin SR 750mg and Rosuvastatin 20mg under fasting 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 20mg orally in the morning on day1 or day8.

Rosuvastatin 20mg

Intervention Type DRUG

Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.

HCP1201, Part 2

Participants received a single oral dose of the HCP1201 750/20mg 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 750/20mg

Intervention Type DRUG

750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Metformin and Rosuvastatin, Part 2

Participants received a single oral dose of coadministration of Metformin SR 750mg and Rosuvastatin 20mg 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 20mg orally in the morning on day1 or day8.

Rosuvastatin 20mg

Intervention Type DRUG

Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.

Interventions

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HCP1201 750/20mg

750mg Metformin/20mg 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 20mg orally in the morning on day1 or day8.

Intervention Type DRUG

Rosuvastatin 20mg

Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.

Intervention Type DRUG

Other Intervention Names

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Glucophage SR 750 mg Crestor 20mg

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteer, age 20\~55 years
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
4. SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
5. History of relevant drug allergies or clinically significant hypersensitivity reaction.
6. History of drug abuse or positive drug screening.
7. Participation in other drug studies within 60days prior to the drug administration.
8. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
9. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
10. Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin.
11. Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial.
12. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
13. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
14. Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication.
15. Clinically inappropriate laboratory test result.
16. Clinically inappropriate electrocardiogram result.
17. Subjects who judged ineligible by the investigator.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JaeWook Ko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-MERO-103

Identifier Type: -

Identifier Source: org_study_id