NCT03849261UnknownPhase 1
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
Chong Kun Dang Pharmaceutical1 site in 1 country36 target enrollmentStarted: January 14, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Cmax of Metformin
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group 1
Experimental
- Period 1: D635
- Period 2: CKD-387
Intervention: CKD-387 (Drug)
Group 2
Experimental
- Period 1: CKD-387
- Period 2: D635
Intervention: CKD-387 (Drug)
Group 1
Experimental
- Period 1: D635
- Period 2: CKD-387
Intervention: D635 (Drug)
Group 2
Experimental
- Period 1: CKD-387
- Period 2: D635
Intervention: D635 (Drug)
Outcomes
Primary Outcomes
Cmax of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin
AUClast of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast of Metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Metformin
Cmax of Dapagliflozin
Time Frame: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Dapagliflozin
Secondary Outcomes
- AUCinf of Dapagliflozin(0 hour ~ 48 hour after drug administration)
- AUCinf of Metformin(0 hour ~ 48 hour after drug administration)
- Tmax of Dapagliflozin(0 hour ~ 48 hour after drug administration)
- Tmax of Metformin(0 hour ~ 48 hour after drug administration)
- T1/2 of Dapagliflozin(0 hour ~ 48 hour after drug administration)
- T1/2 of Metformin(0 hour ~ 48 hour after drug administration)
- Vd/F of Dapagliflozin(0 hour ~ 48 hour after drug administration)
- Vd/F of Metformin(0 hour ~ 48 hour after drug administration)
- CL/F of Dapagliflozin(0 hour ~ 48 hour after drug administration)
- CL/F of Metformin(0 hour ~ 48 hour after drug administration)
Investigators
Study Sites (1)
Loading locations...
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