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Completed

NCT Number: NCT03970434

Drug Concentration of Metformin According to Sampling Method

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Venous blood collection

Other

Venous blood collection

Peripheral Blood Collection

Other

Peripheral blood collection

Primary outcomes

  1. Concentration of Metformin

    Time frame: 10 hours

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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

Clinical Trial to Evaluate Drug Concentration of Metformin According to Sampling Method in Healthy Adult Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 31, 2019
Registry last updated
Jun 13, 2019

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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