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
1 other identifier
interventional
37
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMay 11, 2016
January 1, 2016
1 month
December 22, 2015
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AUClast, Cmax
To evaluate AUClast/Cmax of gemigliptin and rosuvastatin
up to 72h post-dose
Secondary Outcomes (7)
AUCinf
up to 72h post-dose
Tmax
up to 72h post-dose
t1/2
up to 72h post-dose
CL/F
up to 72h post-dose
metabolic ratio
up to 72h post-dose
- +2 more secondary outcomes
Study Arms (2)
Coadministration of G+R
ACTIVE COMPARATORCoadministration of gemigliptin 50mg and rosuvastatin 20mg
Combination G/R
EXPERIMENTALCombination of gemigliptin 50mg / rosuvastatin 20mg
Interventions
gemigliptin/rosuvastatin 50/20mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung Sang Yu, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
February 1, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2016
Study Completion
June 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share