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Completed

NCT Number: NCT02002611

Drug-drug Interaction Study(Lobeglitazone, Warfarin)

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered.

Group 2 is administered in reverse order.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A healthy male volunteer between 19 and 55 years old.
  • BMI between 19 and 27.
  • Signed the informed consent form prior to study participation.
  • Able to participate in the entire trial

Exclusion criteria

  • Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
  • Clinically significant hemorrhagic disease
  • Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
  • Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
  • Participated in the other clinical trials and administrated IP within 60 days prior to screening
  • Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
  • Previously donate whole blood within 60 days or component blood within 30 days
  • sit SBP < 90mmHg or sit SBP ≥ 140mmHg or sit DBP < 60mmHg or sit DBP ≥ 90mmHg
  • A heavy alcohol consumer (alcohol > 140 g/week) or cannot stop drinking
  • A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking
  • A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having
  • Positive for the Triage TOX drug on urine
  • Positive for HIV antibody, HBsAg, HCV antibody test
  • AST, ALT or Total bilirubin > UNL * 1.5
  • Estimated GFR < normal limit
  • INR, aPTT over the normal limit
  • Clinically significant laboratory test result
  • Clinically significant ECG
  • An impossible one who participates in clinical trial by investigator's decision including other reason

Treatment and study plan

Lobeglitazone

Drug

Warfarin

Drug

Primary outcomes

  1. Assess AUC of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  2. Assess Cmax of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  3. Assess AUC of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  4. Assess Cmax of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  5. Assess AUC of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  6. Assess Cmax of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

Secondary outcomes

  1. Assess tmax of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  2. Assess t1/2 of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  3. Assess CL/F of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  4. Assess Vd/F of lobeglitazone

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  5. Assess tmax of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  6. Assess t1/2 of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  7. Assess CL/F of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  8. Assess Vd/F of S-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  9. Assess tmax of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  10. Assess t1/2 of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  11. Assess CL/F of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  12. Assess Vd/F of R-warfarin

    Time frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Jul 3, 2014

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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