Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers

To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: HCP1201, Fasted followed by fed; Drug: HCP1201, Fed followed by fasted

Detailed Description

An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers

• Study Type: Interventional
• Enrollment (Actual): 12
• 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. Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCP1201, Fasted followed by fed; HCP1201 dosing in the fasted state followed by fed dosing	Drug: HCP1201, Fasted followed by fed; There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.; Drug: HCP1201, Fed followed by fasted; There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.
Experimental: HCP1201, Fed followed by fasted; HCP1201 dosing in the fed state followed by fasted dosing	Drug: HCP1201, Fasted followed by fed; There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.; Drug: HCP1201, Fed followed by fasted; There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metformin, rosuvastatin Cmax, 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: Jung Ryul Kim, M.D., Samsung Medical Center

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 7, 2013
• First Submitted That Met QC Criteria: July 14, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: HM-MERO-102