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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: HCP1201 750/20mg; Drug: Metformin SR 750mg; Drug: Rosuvastatin 20mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: HCP1201 750/20mg; 750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
Active Comparator: 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).	Drug: Metformin SR 750mg; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.; Other Names: Glucophage SR 750 mg; Drug: Rosuvastatin 20mg; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.; Other Names: Crestor 20mg
Experimental: 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).	Drug: HCP1201 750/20mg; 750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
Active Comparator: 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).	Drug: Metformin SR 750mg; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.; Other Names: Glucophage SR 750 mg; Drug: Rosuvastatin 20mg; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.; Other Names: Crestor 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
metformin, rosuvastatin Cmax	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
metformin, rosuvastatin AUClast	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Secondary Outcome Measures

Outcome Measure	Time Frame
Metformin, rosuvastatin Tmax	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin T1/2	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin AUCinf	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin CL/F	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin Vd/F	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: JaeWook Ko, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Estimate): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: HM-MERO-103