Drug Concentration of Metformin According to Sampling Method

NCT03970434 | Completed Phase 1

• 1 other identifier: CUH_2019_MSM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Concentration of Metformin

  Compare the concentration of Metformin measured from Venous blood collection and Peripheral blood collection.

  10 hours

Study Arms (1)

Metformin

EXPERIMENTAL

Other: Venous blood collection; Other: Peripheral blood collection

Interventions

Venous blood collection OTHER

Venous blood collection

Metformin

Peripheral blood collection OTHER

Peripheral blood collection

Metformin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Clinical Pharmacology

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 31, 2019
• Study Start: May 30, 2019
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

KR (1)