Clinical trial NCT02212756: Pharmacokinetic Profiles of Metformin With DW1029M
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Metformin After Oral Administration in Healthy Male Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer

Detailed description: A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer

Eligibility criteria: Inclusion Criteria:

* a healthy adult within the range of 19 to 55 years old at the time of screening
* Body Mass Index(BMI)=17.5\~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)
* Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
* Depending on the nature of the drug your doctor check conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged
* The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Institutional Review Board(IRB)-approved consent form signed by the parties in writing

Exclusion Criteria:

* one with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
* one with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
* Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 times the upper limit of the normal range
* Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
* Take part in other clinical trials within two months
* Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg
* The great history of alcohol or drug abuse within 1 year
* Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
* More than 20 cigarettes a day smoker
* Taking medication of a prescription drug or nonprescription within 10 days,
* Within two months the whole blood donation have, within one month of the apheresis donation have
* Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character
* Kidney disease or renal insufficiency (serum creatinine \> 1.5mg/dL(man), 1.4mg/dL(women), or abnormal creatinine clearance) in patients
* Patients with congestive heart failure that requires medication
* Intravenous urography, intravenous cholangiography, angiography, computer tomography(CT) contrast agent for patients
* Investigational product component or biguanide drug in patients with a history of hypersensitivity
* Patients with acute or chronic metabolic acidosis and a history of ketoacidosis
* Severe systemic infection or severe trauma disorders
* Nutritional status, hunger, debilitating condition, pituitary or adrenal dysfunction dysfunction
* Pulmonary infarction, severe lung function disorders and hypoxemia, excessive alcohol intake, party, dehydration, diarrhea, vomiting and other gastrointestinal disorders
* Described lifestyle in this protocol can comply with or can not
* one with other investigator judge to unsuitable

Primary outcomes:
measure: Cmax and AUC
timeFrame: 1d/15d, 5d/19d, 6d/20d : Predose(0,morning), 7d/21d: Predose(0), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 h
Secondary outcomes:
measure: Pharmacokinetic Profile of Plasma
timeFrame: 1d/15d, 5d/19d, 6d/20d: Predose(0, Morning), 7d/21d: Predose(0), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 h
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References: