Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg

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

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.

Study Overview

• Status: Unknown
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: D308 10mg Tab.; Drug: CKD-380 10mg Tab.

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-380 and D308	Area under the CKD-380/D308 concentration in blood-time curve from zero to the final	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
Cmax of CKD-380 and D308	The maximum CKD-380/D308 concentration in blood sampling time t	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Seunghoon Han, Professor, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2018
• Primary Completion (ANTICIPATED): September 21, 2018
• Study Completion (ANTICIPATED): November 9, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 181BE18007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No