Drug Concentration of Metformin According to Sampling Method

Chonbuk National University

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Peripheral blood collection

Other: Venous blood collection

Study type

Interventional

Funder types

Other

Identifiers

NCT03970434

CUH_2019_MSM

Details and patient eligibility

About

This study assess the drug concentration of metformin in healthy adult volunteers according to the sampling method.

Enrollment

20 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects who, at the time of screening, are the age of older than 19 years
Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
There is no congenital disease or within 3 years of chronic diseases
Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests
Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product.
A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
A smoker who consumes more than 20 cigarettes/day within 6 months
A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation