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Clinical Trials/NCT03849261
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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