CClinicalTrials.gg
Sign In
Active, not recruitingNCT05952219Updated Jul 19, 2023

Study to Evaluate the Safety and Pharmacokinetics of CKD-379

A Phase 1 interventional study of CKD-379 and D759+D745+D029+D150 in Type II Diabetes Mellitus, sponsored by Chong Kun Dang Pharmaceutical. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.

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

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

Read the detailed description

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

02

Conditions studied

  • Type II Diabetes Mellitus
03

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 32 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 to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between 19 aged and 50 aged in healthy adult
  • 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

Exclusion criteria

Exclusion Criteria:

  • Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
  • Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
  • Those who are pregnant or breastfeeding
  • Those who are deemed inappropriate to participate in clinical trial by investigators
05

Study design

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

Study arms

  • Experimental
    Sequence 1

    Period 1: Reference drug(D759+D745+D029+D150) Period 2: Test drug(CKD-379)

    Drug: CKD-379 · Drug: D759+D745+D029+D150

  • Experimental
    Sequence 2

    Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D029+D150)

    Drug: CKD-379 · Drug: D759+D745+D029+D150

Interventions

  • DrugCKD-379

    2 tablet administration under fed condition

  • DrugD759+D745+D029+D150

    4 tablet co-administration under fed condition

06

What researchers measure

Primary outcomes

  1. AUCt

    Maximum plasma concentration of the drug

    Time frame: 0~48hours

  2. Cmax

    Area under the concentration-time curve from the time of dosing to the last measurable concentration

    Time frame: 0~48hours

07

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05952219
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jul 19, 2023
Start date
Jun 2, 2023
Primary completion
Jun 19, 2023
Completion
Oct 30, 2023 (estimated)
Last update
Jul 19, 2023

Study contacts

Seol Ju Moon, M.D, Ph.D.
principal investigator · Chonbuk National University Hospital

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2023. 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.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Chong Kun Dang Pharmaceutical

Start the discussion