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CKD-396 Drug-drug Interaction Study(A) (CKD-396 DDI(A) P1)

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ClinicalTrials.gov Identifier: NCT02824874
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Duvie Tab. 0.5mg Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg Phase 1

Detailed Description:
To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Sitagliptin on Pharmacokinetics of Lobeglitazone in Healthy Male Volunteers
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1(Treatment A/Treatment B)

Period 1: Treatment A(Duvie Tab. 0.5mg)*1T/day for 5 days, QD, PO

Period 2: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO

Each treatment period was separated by a washout period of at least 10 dyas.

Drug: Duvie Tab. 0.5mg
Duvie Tab. 0.5mg*1T/day for 5days, QD, PO
Other Name: Lobeglitazone 0.5mg

Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg
Duvie Tab. 0.5mg + Januvia Tab.100mg*1T/day for 5 dyas, QD, PO
Other Name: Lobeglitazone 0.5mg + Sitagliptin 100mg

Experimental: Group 2(Treatment B/Treatment A)

Period 1: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO

Period 2: Treatment A(Duvie Tab. 0.5mg)*1T/day for 5 days, QD, PO

Each treatment period was separated by a washout period of at least 10 dyas.

Drug: Duvie Tab. 0.5mg
Duvie Tab. 0.5mg*1T/day for 5days, QD, PO
Other Name: Lobeglitazone 0.5mg

Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg
Duvie Tab. 0.5mg + Januvia Tab.100mg*1T/day for 5 dyas, QD, PO
Other Name: Lobeglitazone 0.5mg + Sitagliptin 100mg




Primary Outcome Measures :
  1. AUCτ of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  2. Css,max of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]

Secondary Outcome Measures :
  1. Css,min of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  2. Css,av of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  3. Tss,max of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  4. t1/2 of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  5. CLss/F of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  6. Vdss/F of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  7. fluctuation[(Css,max-Css,min)/Css,av] of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]
  8. swing[(Css,max-Css,min)/Css,min] of Lobeglitazone [ Time Frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A healthy male whose age is over 19 years old when visiting for initial screening test
  2. Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
  3. A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
  5. The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
  6. The participants must have an ability and willingness to participate throughout the entire trials

Exclusion Criteria:

  1. A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease.
  2. Who had a gistory of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
  3. Who had following results after examination

    a. ALT or AST > twice higher than normal value

  4. Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g)
  5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
  6. Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or < 60 or ≥ 100(diastolic blood pressure)
  7. Who had a medical history of alcohol and drug abuses.
  8. Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg.
  9. WHo smokes more than 20 eigarettes per day.
  10. Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug.
  11. Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
  12. Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
  13. Who has a histroy of an extreme sensitivity of drugs that contain Rosiglitazone or dugs that have similar effect a Rosiglitazone(Pioglitazone), or drugs that contain the ingredients of Sitagliptin or thiazolidinediones drugs.
  14. Who has a serious heart failure or a congestive heart failure that must be drug-treated
  15. A patient with hepatopathy.
  16. A patient with wevere nephropathy.
  17. Who has diabetic ketoacidosis or a diaetic coma, or type 1 diabetes, or has history of acute metablic acidosis or ketoacidosis.
  18. A patient with serious infectious disease or severe injuries before and after a surgery.
  19. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
  20. Test subjects who is not willing or unable to comply with guidelines described in this protocol.
  21. A person who is not determined unsuitable to participate in this test by the researchers.

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): NCT02824874


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Study Director: Min-Gul Kim, MD,PhD Chonbuk National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02824874    
Other Study ID Numbers: 165DDI16002
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
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