BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: gemigliptin 50mg, rosuvastatin 20mg

Detailed Description

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects(at screening)
• BMI between 18.0 - 27.0
• FPG 70-125mg/dL glucose level(at screening)
• Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

• Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
• Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
• Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
• Subject who already participated in other trials in 2months
• Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.
• Heavy smokers.(>10 cigarettes per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coadministration of G+R; Coadministration of gemigliptin 50mg and rosuvastatin 20mg	Drug: gemigliptin 50mg, rosuvastatin 20mg; gemigliptin/rosuvastatin 50/20mg; Other Names: Zemiglo, Cresto
Experimental: Combination G/R; Combination of gemigliptin 50mg / rosuvastatin 20mg	Drug: gemigliptin 50mg, rosuvastatin 20mg; gemigliptin/rosuvastatin 50/20mg; Other Names: Zemiglo, Cresto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast, Cmax	To evaluate AUClast/Cmax of gemigliptin and rosuvastatin	up to 72h post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose
Tmax	To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose
t1/2	To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose
CL/F	To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin	up to 72h post-dose
metabolic ratio	To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite	up to 72h post-dose
AUEC	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.	up to 72h post-dose
Emax	This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.	up to 72h post-dose

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Investigators: Principal Investigator: Kyung Sang Yu, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: LG-GSCL003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO