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Completed

NCT Number: NCT01823133

Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin only

Drug

gemigliptin 50mg qd on day 1~7

rosuvastatin only

Drug

rosuvastatin 20mg qd on day 1~7

gemigliptin and rosuvastatin

Drug

gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7

Primary outcomes

  1. Cmax

    Time frame: up to 72 hour post dose

    to evaluate Cmax of gemigliptin and rosuvastatin at steady state

  2. 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 outcomes

  1. 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

  2. Cmin

    Time frame: upto 72 hour post dose

    to evaluate Cmin of gemigliptin and rosuvastatin at steady state

  3. t1/2β

    Time frame: upto 72 hour post dose

    to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin

  4. Cmax

    Time frame: upto 72 hour post dose

    to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  5. AUC

    Time frame: upto 72 hour post dose

    to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state

  6. metabolic ratio

    Time frame: upto 72 hour post dose

    to evaluate metabolic ratio of gemiglipin and rosuvastatin

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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