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

NCT01929512 | Completed Phase 1

• 1 other identifier: HM-MERO-103
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (4)

HCP1201, Part 1

EXPERIMENTAL

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

Metformin and Rosuvastatin, Part1

ACTIVE COMPARATOR

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; Drug: Rosuvastatin 20mg

HCP1201, Part 2

EXPERIMENTAL

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

Metformin and Rosuvastatin, Part 2

ACTIVE COMPARATOR

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; Drug: Rosuvastatin 20mg

Interventions

HCP1201 750/20mg DRUG

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

HCP1201, Part 1; HCP1201, Part 2

Metformin SR 750mg DRUG

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

Also known as: Glucophage SR 750 mg

Metformin and Rosuvastatin, Part 2; Metformin and Rosuvastatin, Part1

Rosuvastatin 20mg DRUG

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

Also known as: Crestor 20mg

Metformin and Rosuvastatin, Part 2; Metformin and Rosuvastatin, Part1

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Subject who has the ability and willingness to participate the whole period of trial

You may not qualify if:

• 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.
• Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
• Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
• SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
• History of relevant drug allergies or clinically significant hypersensitivity reaction.
• History of drug abuse or positive drug screening.
• Participation in other drug studies within 60days prior to the drug administration.
• Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
• 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)
• 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.
• Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial.
• Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
• Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
• Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication.
• Clinically inappropriate laboratory test result.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• JaeWook Ko, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 28, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

KR (1)