Clinical trial NCT03849261: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. 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
3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
4. Participated in a clinical trial within 90 days prior to 1st IP dosing
5. Not eligible to participate for the study at the discretion of Investigator
6. Other exclusive inclusion criteria, as defined in the protocol

Primary outcomes:
measure: Cmax of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Cmax of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: AUClast of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: AUClast of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
measure: AUCinf of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: AUCinf of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Tmax of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Tmax of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: T1/2 of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: T1/2 of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Vd/F of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Vd/F of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: CL/F of Dapagliflozin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: CL/F of Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References: