NCT02011633

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-12-13
• Last updated: 2014-03-11

Locations

1 site across 1 country: South Korea