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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901757
• Other study ID #: HM-MERO-102
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2013
• Last updated: August 12, 2013
• Start date: June 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No