Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01823133
First received: March 28, 2013
Last updated: August 27, 2013
Last verified: August 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    to evaluate Cmax of gemigliptin and rosuvastatin at steady state

  • AUC [ Time Frame: up to 72 hour post dose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin

  • Cmin [ Time Frame: upto 72 hour post dose ] [ Designated as safety issue: No ]
    to evaluate Cmin of gemigliptin and rosuvastatin at steady state

  • t1/2β [ Time Frame: upto 72 hour post dose ] [ Designated as safety issue: No ]
    to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin

  • Cmax [ Time Frame: upto 72 hour post dose ] [ Designated as safety issue: No ]
    to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  • AUC [ Time Frame: upto 72 hour post dose ] [ Designated as safety issue: No ]
    to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  • metabolic ratio [ Time Frame: upto 72 hour post dose ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823133

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

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01823133     History of Changes
Other Study ID Numbers: LG-GSCL001
Study First Received: March 28, 2013
Last Updated: August 27, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 10, 2014