Clinical trial NCT03601910: Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg
Official title: An Open-label, Randomized, Fasted, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 34
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.

Detailed description: To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab.

Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility criteria: Inclusion Criteria:

1. 19 to 45 years old healthy male subject at the screening
2. Subject with a body weight more than 50kg and less than ±20% of ideal body weight at the screening(\* Ideal body weight = {Height(cm) - 100}x0.9)
3. Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study

Exclusion Criteria:

1. Subject who has a disease or history of clinically significant cardiovascular system, respirator, kidney, endocrine system, blood system, digestive system, central nervous system(CNS), urinary system, musculoskeletal system, psychiatric system or malignant tumor etc.
2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect investigational product absorption
3. Subject who has hypersensitivity to Investigational product(or additives) or any other medicines or medical history of clinically significant hypersensitivity
4. Subject who is determined unsuitable for clinical studyl participation by Health Examination(Disease, past disease history Physical, vital sign, Electrocardiography, laboratory test etc.) at the screening
5. Subject who has laboratory test results at the screening as below 1) AST or AST \> 1.25 times upper limit of normal range 2) Total bilirubin \> 1.25 times upper limit of normal range 3) eGFR (estimated Glomerular Filtration Rate) \< 60 mL/min/1.73 m2 4) Positive results of HBsAg, Anti-HCV Ab, HIV Ag/Ab and Syphilis reagin test 5) Glucose(under fasting condition) \< 50mg/dL or \>110mg/dL
6. Subject who has hypersensitivity to investigational product, peanut, or bean
7. Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
8. Subject who shows Systolic Blood Pressure ≥140 or \<90 mmHg or Diastolic Blood Pressure ≥90 or \<60 mmHg at screening after rest longer than 5 minute at the screening
9. Subject who has history of drug abuse
10. Subject who has too much caffeine and alcohol(Caffeine: \> 5 cup/day, Alcohol \> 210 g/week) / Smoker(\>10 cigarettes/day)
11. Subject who had the Investigational Product(IP) administration at other clinical studies or bioequivalence tests within 90 days prior to the first IP administration
12. Subject who has taken drug-metabolizing enzyme induction and/or inhibition drug(such as barbital, etc.) within 30days prior to the first Investigational Product administration
13. Subject who has donated whole blood within 60 days or component blood within 30days prior to the first Investigational Product administration
14. Subject who has foods containing grapefruit within 7days prior to the first Investigational Product administration
15. Subject who has taken ETC(Ethical The Counter) Drug or herb medicine within 14 days or OTC(Over The Counter) Drug or vitamin supplement within 7 days prior to the first Investigational Product administration
16. Subject who is nat able to have foods containing caffeine, drinking alcohol or Smoking during from 24hours before admission to discharge hospitalization
17. Subject who is not eligible for participation in clinical study by investigator's decision including another reason

Primary outcomes:
measure: AUCt of CKD-380 and D308
timeFrame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
measure: Cmax of CKD-380 and D308
timeFrame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Seunghoon Han, Professor
role: PRINCIPAL_INVESTIGATOR
References: