ClinicalTrials.gg
Status unknownNCT04246190Updated Feb 5, 2020

A Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-396

A Phase 1 interventional study of CKD-501 and D759 and CKD-396 in Type2 Diabetes Mellitus, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

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

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the pharmacokinetics and safety of CKD-396.

Read the detailed description

Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-396 and Co-administration of CKD-501 and D759 in Healthy Adults

02

Conditions studied

  • Type2 Diabetes Mellitus
03

In context

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 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 to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult who is 19 \~ 55 years at the time of screening
  2. Body weight more than 55 kg for male and more than 50kg for female
  3. BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
  4. Females must be menopause or surgical infertility
  5. Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
  6. Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
  2. Subjects who have diabetic ketoacidoisis, diabetic coma, diabetic precoma, Type 1 diabetes
  3. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  4. Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
  5. Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product(lobeglitazone, sitagliptin) and same class drug with thiazolidinediones
  6. Subjects who have severe infectious disease and severe trauma before and after operation
  7. Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product

    • AST, ALT> UNL(Upper Normal Limit)x1.25
    • Total bilirubin > UNL(Upper Normal Limit)x1.5
    • eGFR (Estimated Glomerular Filtration Rate) \<60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
    • Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
    • After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or \< 90 mmHg, diastolic blood pressure> 100 mmHg or \<50 mmHg
  8. Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
  9. Pregnant or lactating women
  10. Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
  11. Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons

    • Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug.
    • Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
  12. Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
  13. Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
  14. Subjects who received a blood transfusion within 60 days before the first dose of the investigational product
  15. Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
05

Study design

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

Study arms

  • Experimental
    Group 1

    * Period 1: CKD-501 and D759 * Period 2: CKD-396

    Drug: CKD-501 and D759 · Drug: CKD-396

  • Experimental
    Group 2

    * Period 1: CKD-396 * Period 2: CKD-501 and D759

    Drug: CKD-501 and D759 · Drug: CKD-396

Interventions

  • DrugCKD-501 and D759

    Reference drug, CKD-501 1T and D759 1T, QD, PO

  • DrugCKD-396

    Reference drug, CKD-396 1T, QD, PO

06

What researchers measure

Primary outcomes

  1. Cmax of CKD-501, D759 and CKD-396

    Maximum plasma concentration of CKD-501, D759 and CKD-396

    Time frame: 0(predose)~48 hours

  2. AUClast of CKD-501, D759 and CKD-396

    Area under the plasma concentration-time curve to last concentration of CKD-501, D759 and CKD-396

    Time frame: 0(predose)~48 hours

07

Study locations

1 site
  • Yonsei University Severance Hospital
    Soeul, South Korea
    • Min Soo Park, Ph.D. M.D · Contact · minspark@yuhs.ac · +82-2-2228-0401
    • Min Soo Park, Ph.D. M.D · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2020; primary completion for Apr 2020, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2020
First posted
Jan 29, 2020
StartEst.
Feb 24, 2020
Primary completionEst.
Apr 10, 2020
CompletionEst.
Jul 16, 2020
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04246190
Responsible party
Sponsor
First posted
Jan 29, 2020
Start date
Feb 24, 2020 (estimated)
Primary completion
Apr 10, 2020 (estimated)
Completion
Jul 16, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

Min Soo Park, Ph.D. M.D
Contact
minspark@yuhs.ac
+82-2-2228-0401
Min Soo Park, Ph.D. M.D
principal investigator · Severance Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion