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

NCT02011633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HCP1201 500/10mg

500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

DRUG

Metformin SR 500mg

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

DRUG

Rosuvastatin 10mg

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Wooseong Huh, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011633 on ClinicalTrials.gov