Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg

Diabetes Mellitus Clinical Trial

Official title:

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011633
• Other study ID #: HM-MERO-105
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2013
• Last updated: March 10, 2014
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• 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 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 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 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study

• History of relevant drug allergies or clinically significant hypersensitivity reaction.

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 500/10mg
500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
• Metformin SR 500mg
Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
• Rosuvastatin 10mg
Co-administration of Metformin 500mg and Rosuvastatin 10mg 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