HealthyPhase 1PMDNCT02212756
Pharmacokinetic Profiles of Metformin With DW1029M
A Phase 1 study testing DW1029M 1200mg and Metformin 1000mg and Metformin 1000mg in people with Healthy, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DW1029M 1200mg and Metformin 1000mg and Metformin 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
About this study
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
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
- Conditions
- Healthy
- Being tested
- DW1029M 1200mg and Metformin 1000mg, Metformin 1000mg
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1029M 1200mg and Metformin 1000mgDrug
Also called Concomitant of DW1029M 1200mg and Metformin 1000mg
Metformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days
Metformin 1000mgDrug
Also called Diabex tab. 500mg
Metformin 500mg b.i.d. for 7 days
| Study group | Role | What they receive |
|---|---|---|
| B Group | Experimental | 1st oral administration of Metformin 1000mg and 2nd oral administration of Metformin 1000mg and DW1029M 1200mg Receives: Drug: DW1029M 1200mg and Metformin 1000mg; Drug: Metformin 1000mg |
| A Group | Experimental | 1st oral administration of DW1029M 1200mg and Metformin 1000mg and 2nd oral administration of Metformin 1000mg Receives: Drug: DW1029M 1200mg and Metformin 1000mg; Drug: Metformin 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUC
Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)
Measured: 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]
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, M.D, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212756
- Sponsor's protocol ID
- DW1029M-I-4
- Acronym
- PMD
- Status last verified
- Jun 2015
- First submitted
- 5 Aug 2014
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02212756
- Acronym / sponsor ID
- PMD / DW1029M-I-4
- Conditions
- Healthy
- Keywords
- healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B Group | Experimental | Drug: DW1029M 1200mg and Metformin 1000mg, Drug: Metformin 1000mg1st oral administration of Metformin 1000mg and 2nd oral administration of Metformin 1000mg and DW1029M 1200mg |
| A Group | Experimental | Drug: DW1029M 1200mg and Metformin 1000mg, Drug: Metformin 1000mg1st oral administration of DW1029M 1200mg and Metformin 1000mg and 2nd oral administration of Metformin 1000mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DW1029M 1200mg and Metformin 1000mgAlso: Concomitant of DW1029M 1200mg and Metformin 1000mgMetformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days | Drug | A Group, B Group |
| Metformin 1000mgAlso: Diabex tab. 500mgMetformin 500mg b.i.d. for 7 days | Drug | A Group, B Group |
Primary outcome
Cmax and 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
Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)
1 secondary outcome
Pharmacokinetic Profile of Plasma
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingul Kim, M.D principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DW1029M 1200mg and Metformin 1000mg and Metformin 1000mg in people with Healthy, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax and 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.