An integrative pharmacogenetic - pharmacometabolomic study to predict individualized pharmacokinetics of glimepiride in healthy Korean male subjects

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0001829
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1) Healthy male subject aged =19 years at screening
2) Body weight of = 50 kg and within ± 20% of ideal body weight
? IBW (kg) = height (cm) - 100} * 0.9
3) Subject that is considered eligible for medical history and physical examination conducted in accordance with the study protocol, with no congenital or chronic disease
4) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, prior to administration of study drug (results : normal or no clinical significant)
5) Subjects who understand a detailed explanation of the study protocol, voluntarily decide to participate and follow the study instructions, and sign Informed Consent

Exclusion Criteria

1) Medical History of clinically significant hypersensitivity to Glimepiride, sulfonylurea, sulfonamide (major ingredient or any other ingredient)
2) congenital or chronic disease(endocrine disease(ex,Diabetes Mellitus), etc), pathological symptoms or findings of medical examination
3) History of gastrointestinal disease (e.g., Crohn’s disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
4) History of major injury, surgical operation, or suspected symptom of acute illness within 4 weeks prior to the first administration of study drug
5) history of drug abuse
6) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
7) Participation in any other study within 3 months prior to the first administration of study drug (The completion date of previous study is the day of the last administration of study drug)
8) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
9) History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period
10)Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice = 1L /day within 7 days prior to administration of study drug)
11)Positive serologic tests (HBsAg, HCV Ab(Hepatitis C Virus anti-body), HIV Ag/Ab, VDRL(venereal disease research laboratory))
12)Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
13)Subject that is not eligible to participate at the discretion of study investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) or any other reason

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUCinf - AUClast, Cmax, Tmax,t½

Secondary Outcome Measures

Name	Time	Method
physical examination, vital sign, AE