Drug Concentration of Metformin According to Sampling Method

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Venous blood collection; Other: Peripheral blood collection

• Registration Number: NCT03970434
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-17
• Study Start: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Status Verified: 2019-06
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Venous blood collection	-
Metformin	Peripheral blood collection	-

Primary Outcome Measures

Name	Time	Method
Concentration of Metformin	10 hours	Compare the concentration of Metformin measured from Venous blood collection and Peripheral blood collection.

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of