AzTrials
AzTrials

Type2 Diabetes MellitusPhase 1NCT03849261

Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

A Phase 1 study testing CKD-387 and D635 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type2 Diabetes Mellitus
What is being tested?
CKD-387 and D635
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
14 Jan 2019to 22 Feb 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 19 to 55 years
  • Females must be menopause or surgical infertility
  • Signed informed consent form
  • Other inclusion criteria, as defined in the protocol

Who cannot join

  • History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  • Clinical laboratory test values are outside the accepted normal range at Screening
  • aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
  • Total Bilirubin > 1.5 times the upper limit of the normal range
  • creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
  • estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
Show all 12Show fewer
  • Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
  • systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg
  • Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
  • Participated in a clinical trial within 90 days prior to 1st IP dosing
  • Not eligible to participate for the study at the discretion of Investigator
  • Other exclusive inclusion criteria, as defined in the protocol

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults.

Being tested
CKD-387, D635

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-387Drug

    Test drug

  • D635Drug

    Reference drug

Study groups in NCT03849261
Study groupRoleWhat they receive
Group 1Experimental* Period 1: D635 * Period 2: CKD-387
Receives: Drug: CKD-387; Drug: D635
Group 2Experimental* Period 1: CKD-387 * Period 2: D635
Receives: Drug: CKD-387; Drug: D635

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Dapagliflozin

    Maximum plasma concentration of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  2. Cmax of Metformin

    Maximum plasma concentration of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

  3. AUClast of Dapagliflozin

    Area under the plasma concentration-time curve to last concentration of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  4. AUClast of Metformin

    Area under the plasma concentration-time curve to last concentration of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

Secondary outcomes (10)

  1. AUCinf of Dapagliflozin

    Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  2. AUCinf of Metformin

    Area under the plasma concentration-time curve from zero to infinity concentration of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

  3. Tmax of Dapagliflozin

    Time to maximum plasma concentration of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  4. Tmax of Metformin

    Time to maximum plasma concentration of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

  5. T1/2 of Dapagliflozin

    Half-life of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  6. T1/2 of Metformin

    Half-life of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

  7. Vd/F of Dapagliflozin

    Apparent volume of distribution of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  8. Vd/F of Metformin

    Apparent volume of distribution of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

  9. CL/F of Dapagliflozin

    Apparent clearance of Dapagliflozin

    Measured: 0 hour ~ 48 hour after drug administration

  10. CL/F of Metformin

    Apparent clearance of Metformin

    Measured: 0 hour ~ 48 hour after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start14 Jan 2019
  3. Primary completion1 Feb 2019
  4. Study completion22 Feb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03849261
Sponsor's protocol ID
184BE18026
Status last verified
Feb 2019
First submitted
20 Feb 2019
Last updated
21 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-387 and D635 in people with Type2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Dapagliflozin (time frame: 0 hour ~ 48 hour after drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03849261.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in