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CompletedNCT02212756PMDUpdated Jun 29, 2015

Pharmacokinetic Profiles of Metformin With DW1029M

A Phase 1 interventional study of DW1029M 1200mg and Metformin 1000mg and Metformin 1000mg in Healthy, sponsored by Dong Wha Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-29.

Sponsored by Dong Wha Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

  • Healthy

Keywords

  • healthy
03

In context

Lead sponsor

Dong Wha Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    B Group

    1st oral administration of Metformin 1000mg and 2nd oral administration of Metformin 1000mg and DW1029M 1200mg

    Drug: DW1029M 1200mg and Metformin 1000mg · Drug: Metformin 1000mg

  • Experimental
    A Group

    1st oral administration of DW1029M 1200mg and Metformin 1000mg and 2nd oral administration of Metformin 1000mg

    Drug: DW1029M 1200mg and Metformin 1000mg · Drug: Metformin 1000mg

Interventions

  • DrugDW1029M 1200mg and Metformin 1000mg

    Metformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days

    Also known as: Concomitant of DW1029M 1200mg and Metformin 1000mg

  • DrugMetformin 1000mg

    Metformin 500mg b.i.d. for 7 days

    Also known as: Diabex tab. 500mg

06

What researchers measure

Primary outcomes

  1. Cmax and AUC

    Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)

    Time frame: 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

  1. Pharmacokinetic Profile of Plasma

    Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation\[(Css,max-Css,min)/Css,av\], Swing\[(Css,max-Css,min)/Css,min\]

    Time frame: 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

07

Study locations

1 site
  • Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 561-712, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02212756
Lead sponsor
Dong Wha Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Aug 8, 2014
Start date
Aug 2014
Primary completion
Jan 2015
Completion
Feb 2015
Last update
Jun 29, 2015

Study contacts

Mingul Kim, M.D
principal investigator · Chonbuk National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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