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Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823133
First Posted: April 4, 2013
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LG Life Sciences
  Purpose
Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

Condition Intervention Phase
Healthy Drug: gemigliptin only Drug: rosuvastatin only Drug: gemigliptin and rosuvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Cmax [ Time Frame: up to 72 hour post dose ]
    to evaluate Cmax of gemigliptin and rosuvastatin at steady state

  • AUC [ Time Frame: up to 72 hour post dose ]
    to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state


Secondary Outcome Measures:
  • Tmax [ Time Frame: up to 72 hour post dose ]
    to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin

  • Cmin [ Time Frame: upto 72 hour post dose ]
    to evaluate Cmin of gemigliptin and rosuvastatin at steady state

  • t1/2β [ Time Frame: upto 72 hour post dose ]
    to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin

  • Cmax [ Time Frame: upto 72 hour post dose ]
    to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  • AUC [ Time Frame: upto 72 hour post dose ]
    to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  • metabolic ratio [ Time Frame: upto 72 hour post dose ]
    to evaluate metabolic ratio of gemiglipin and rosuvastatin


Estimated Enrollment: 30
Study Start Date: April 2013
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gemigliptin only
Multiple administrations of gemigliptin
Drug: gemigliptin only
gemigliptin 50mg qd on day 1~7
Experimental: rosuvastatin only
Multiple administrations of rosuvastatin
Drug: rosuvastatin only
rosuvastatin 20mg qd on day 1~7
Experimental: gemigliptin and rosuvastatin
Multiple administrations of gemigliptin and rosuvastatin
Drug: gemigliptin and rosuvastatin
gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 to 45, healthy male subjects (at screening)
  • BMI between 18 - 27 kg/m2 (at screening)
  • Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
  • 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

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 that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
  • Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
  • Subject who already admitted in other investigator product in 80 days
  • Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
  Contacts and Locations
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): NCT01823133


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01823133     History of Changes
Other Study ID Numbers: LG-GSCL001
First Submitted: March 28, 2013
First Posted: April 4, 2013
Last Update Posted: August 28, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors