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the Pharmacokinetic Profiles of Linagliptin With DW1029M (PLID)

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ClinicalTrials.gov Identifier: NCT02212782
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Linagliptin 5mg Drug: DW1029M 1200mg and Linagliptin 5mg Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Linagliptin After Oral Administration in Healthy Male Volunteer
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: A Group
1st oral administration of Linagliptin 5mg and 2nd oral administration of DW1029M 1200mg and Linagliptin 5mg
Drug: Linagliptin 5mg
Linagliptin 5mg once daily for 7 days
Other Name: Trajenta Tablet

Drug: DW1029M 1200mg and Linagliptin 5mg
Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
Other Name: Concomitant of DW1029M 1200mg and Linagliptin 5mg

Experimental: B Group
1st oral administration of DW1029M 1200mg and Linagliptin 5mg and 2nd oral administration of Linagliptin 5mg
Drug: Linagliptin 5mg
Linagliptin 5mg once daily for 7 days
Other Name: Trajenta Tablet

Drug: DW1029M 1200mg and Linagliptin 5mg
Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
Other Name: Concomitant of DW1029M 1200mg and Linagliptin 5mg




Primary Outcome Measures :
  1. Cmax and AUC [ Time Frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour ]
    Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)


Secondary Outcome Measures :
  1. Pharmacokinetic Profile of Plasma [ Time Frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour ]
    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]



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • Doctor checks 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
  • Patient with hypersensitivity to investigational products or ingredients
  • Patient with Type 1 Diabetes or Diabetic ketoacidosis
  • Described lifestyle in this protocol can comply with or can not
  • One with other investigator judge to unsuitable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212782


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabukdo, Korea, Republic of, 561-712
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: Mingul Kim, M.D Chonbuk National University Hospital

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Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT02212782     History of Changes
Other Study ID Numbers: DW1029M-I-6
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: February 2015
Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
Healthy
Additional relevant MeSH terms:
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Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action