- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849261
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults
February 20, 2019 updated by: Chong Kun Dang Pharmaceutical
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
|
Test drug
Reference drug
|
EXPERIMENTAL: Group 2
|
Test drug
Reference drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Maximum plasma concentration of Metformin
|
0 hour ~ 48 hour after drug administration
|
Cmax of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Maximum plasma concentration of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
AUClast of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
AUClast of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Area under the plasma concentration-time curve to last concentration of Metformin
|
0 hour ~ 48 hour after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CL/F of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Apparent clearance of Metformin
|
0 hour ~ 48 hour after drug administration
|
Vd/F of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Apparent volume of distribution of Metformin
|
0 hour ~ 48 hour after drug administration
|
AUCinf of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
AUCinf of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
|
0 hour ~ 48 hour after drug administration
|
Tmax of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Time to maximum plasma concentration of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
Tmax of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Time to maximum plasma concentration of Metformin
|
0 hour ~ 48 hour after drug administration
|
T1/2 of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Half-life of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
T1/2 of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Half-life of Metformin
|
0 hour ~ 48 hour after drug administration
|
Vd/F of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Apparent volume of distribution of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
CL/F of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
|
Apparent clearance of Dapagliflozin
|
0 hour ~ 48 hour after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 14, 2019
Primary Completion (ACTUAL)
February 1, 2019
Study Completion (ANTICIPATED)
February 22, 2019
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 20, 2019
First Posted (ACTUAL)
February 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 184BE18026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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