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

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ClinicalTrials.gov Identifier: NCT02670070
Recruitment Status : Unknown
Verified January 2016 by LG Life Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : February 1, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: gemigliptin 50mg, rosuvastatin 20mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: Zemiglo, Cresto

Experimental: Combination G/R
Combination of gemigliptin 50mg / rosuvastatin 20mg
Drug: gemigliptin 50mg, rosuvastatin 20mg
gemigliptin/rosuvastatin 50/20mg
Other Name: Zemiglo, Cresto




Primary Outcome Measures :
  1. AUClast, Cmax [ Time Frame: up to 72h post-dose ]
    To evaluate AUClast/Cmax of gemigliptin and rosuvastatin


Secondary Outcome Measures :
  1. AUCinf [ Time Frame: up to 72h post-dose ]
    To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin

  2. Tmax [ Time Frame: up to 72h post-dose ]
    To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin

  3. t1/2 [ Time Frame: up to 72h post-dose ]
    To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin

  4. CL/F [ Time Frame: up to 72h post-dose ]
    To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin

  5. metabolic ratio [ Time Frame: up to 72h post-dose ]
    To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite

  6. AUEC [ Time Frame: up to 72h post-dose ]
    This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.

  7. Emax [ Time Frame: up to 72h post-dose ]
    This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670070


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
LG Life Sciences
Investigators
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Principal Investigator: Kyung Sang Yu, MD, PhD Seoul National University Hospital
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02670070    
Other Study ID Numbers: LG-GSCL003
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors