Overview

Pharmacokinetic Profiles of Metformin With DW1029M

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
Male
Summary
Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dong Wha Pharmaceutical Co. Ltd.
Treatments:
Metformin
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