Clinical trial NCT04156685: Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
Official title: An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2 Diabetes Mellitus
Keywords: Type2 Diabetes Mellitus
CKD-387
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 part, 2x2 crossover study
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387

Detailed description: An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult older than 19 years and less than 45 years at the time of screening.
2. BMI 18.5\~29.9 kg/m2 and body weight more than 50kg.
3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
4. Subjects who sign on an informed consent form willingly.

Exclusion Criteria:

1. Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
2. Subjects who have acute disease within 28 days prior to the first administration.
3. Subjects who have history that may affect the ADME.
4. Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
5. Subjects who have clinically significant chronic disease.
6. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
7. Subjects whose laboratory test result are same as below;

   * AST,ALT \> UNL(Upper Normal Limit)x3
   * Fasting glucose level out of 70-125mg/dl
   * Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
   * QT\>450msec
   * Positive urine hCG(female).
8. Subjects whoes blood pressure exceeds out of normal range as below at screening.

   * SBP : over 100mmHg, under 160mmHg
   * DBP : over 60mmHg, under 100mmHg
9. Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
10. Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
11. Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
12. Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
13. Subjects who can not eat standard meals provided by the institution.
14. Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
15. Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
16. Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
17. Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
18. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice\>1L/day or Caffein\>5Cups/day).
19. Subjects who have took regular alcohol(alcohol\>30g/day) prior to the first administration of investigational products.
20. Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
21. Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
22. Lactating Women.

Primary outcomes:
measure: Part A : Cmax under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : Cmax under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : AUClast under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : AUClast under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part B : Cmax under fed condition
timeFrame: 0(predose)~48 hours
measure: Part B : AUClast under fed condition
timeFrame: 0(predose)~48 hours
Secondary outcomes:
measure: Part A : AUCinf under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : AUCinf under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : Tmax under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : Tmax under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : t1/2 under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part A : t1/2 under fasting condition
timeFrame: 0(predose)~48 hours
measure: Part B : AUCinf under fed condition
timeFrame: 0(predose)~48 hours
measure: Part B : Tmax under fed condition
timeFrame: 0(predose)~48 hours
measure: Part B : t1/2 under fed condition
timeFrame: 0(predose)~48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-Gu
Study officials:
affiliation: Korea University Anam Hospital / Seoul, Seongbuk-Gu, South Korea
name: Ji-Young Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: