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CompletedNCT02824874Updated Jul 11, 2016

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

A Phase 1 interventional study of Duvie Tab. 0.5mg and Duvie Tab. 0.5mg + Januvia Tab. 100mg in Diabetes Mellitus, Type II, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type II
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In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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 · Drug: Duvie Tab. 0.5mg + Januvia Tab. 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 · Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg

Interventions

  • DrugDuvie Tab. 0.5mg

    Duvie Tab. 0.5mg\*1T/day for 5days, QD, PO

    Also known as: Lobeglitazone 0.5mg

  • DrugDuvie Tab. 0.5mg + Januvia Tab. 100mg

    Duvie Tab. 0.5mg + Januvia Tab.100mg\*1T/day for 5 dyas, QD, PO

    Also known as: Lobeglitazone 0.5mg + Sitagliptin 100mg

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Chonbuk National University Hospital
    Jeonju-si, Korea, Republic of
08

References and documents

Publications

  • Moon SJ, Yu KS, Kim MG. An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men. Clin Ther. 2020 Jun;42(6):1047-1057. doi: 10.1016/j.clinthera.2020.04.005. Epub 2020 Apr 30. PubMed 32362346 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02824874
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Apr 2016
Primary completion
Apr 2016
Completion
May 2016
Last update
Jul 11, 2016

Study contacts

Min-Gul Kim, MD,PhD
study director · Chonbuk National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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