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OpenTrials
Completed

NCT Number: NCT02954822

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

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Key information

Conditions

Type2 Diabetes

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center, Seoul National University Hospital

Seoul, 03080, South Korea

About this study

A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Male Volunteers (Age: 19~45years)
  • 55<Body Weight<90, 18<BMI<27
  • FPG: 70-125 mg/dL

Exclusion criteria

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Clinically significant Medical History
  • Allergy or Drug Hypersensitivity
  • AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min
  • Drink during clinical trial period
  • Smoking during clinical trial period
  • Grapefruit/Caffeine intake during clinical trial period
  • No Contraception

Treatment and study plan

Evogliptin→Evogliptin+Glimepiride→Glimepiride

Drug

Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.

Glimepiride : Glimepiride 4mg QD

Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

Other names: Suganon, Amaryl

Glimepiride→Evogliptin→Evogliptin+Glimepiride

Drug

After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Other names: Suganon, Amaryl

Primary outcomes

  1. AUCτ,ss for Evogliptin and Glimepiride

    Time frame: 3 weeks

    area under the concentration-time curve

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Sep 18, 2017

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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