Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A group Period 1: D308 10mg Tab. 1T Period 2: CKD-380 10mg Tab. 1T |
Drug: D308 10mg Tab.
D308 10mg Tab.1T single oral administration under fasting condition
Drug: CKD-380 10mg Tab.
CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition
|
| Experimental: B group Period 1: CKD-380 10mg Tab. 1T Period 2: D308 10mg Tab. 1T |
Drug: D308 10mg Tab.
D308 10mg Tab.1T single oral administration under fasting condition
Drug: CKD-380 10mg Tab.
CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition
|
Outcome Measures
Primary Outcome Measures
- AUCt of CKD-380 and D308 [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]
Area under the CKD-380/D308 concentration in blood-time curve from zero to the final
- Cmax of CKD-380 and D308 [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]
The maximum CKD-380/D308 concentration in blood sampling time t
Eligibility Criteria
Criteria
Inclusion Criteria:
-
19 to 45 years old healthy male subject at the screening
-
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)
-
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:
-
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.
-
Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect investigational product absorption
-
Subject who has hypersensitivity to Investigational product(or additives) or any other medicines or medical history of clinically significant hypersensitivity
-
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
-
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
-
Subject who has hypersensitivity to investigational product, peanut, or bean
-
Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
-
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
-
Subject who has history of drug abuse
-
Subject who has too much caffeine and alcohol(Caffeine: > 5 cup/day, Alcohol > 210 g/week) / Smoker(>10 cigarettes/day)
-
Subject who had the Investigational Product(IP) administration at other clinical studies or bioequivalence tests within 90 days prior to the first IP administration
-
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
-
Subject who has donated whole blood within 60 days or component blood within 30days prior to the first Investigational Product administration
-
Subject who has foods containing grapefruit within 7days prior to the first Investigational Product administration
-
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
-
Subject who is nat able to have foods containing caffeine, drinking alcohol or Smoking during from 24hours before admission to discharge hospitalization
-
Subject who is not eligible for participation in clinical study by investigator's decision including another reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
- Principal Investigator: Seunghoon Han, Professor, The Catholic University of Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 181BE18007