NCT02378441

Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg

A Randomized, Open-labeled, Single-dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety of CJ-30056 20/750mg and Co-administration of Lipitor® 20mg and Glucophage SR 750mg in Fed Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and metformin SR 750mg, in healthy volunteers.

Detailed description

To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg and Metformin SR 750mg	co-administration of Atorvastatin 20mg and Metformin SR 750mg
DRUG	CJ-30056 20/750mg	fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-03-01
• Completion: 2015-08-01
• First posted: 2015-03-04
• Last updated: 2016-12-30