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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929512
• Other study ID #: HM-MERO-103
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2013
• Last updated: August 29, 2013
• Start date: June 2013
• Est. completion date: August 2013

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2013
• Est. primary completion date: August 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. 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 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 750/20mg
750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
• Metformin SR 750mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
• Rosuvastatin 20mg
Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.

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		pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h	No
Primary	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	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