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

NCT03601910 | Unknown Phase 1

• 1 other identifier: 181BE18007
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

A group

EXPERIMENTAL

1. Period 1: D308 10mg Tab. 1T 2. Period 2: CKD-380 10mg Tab. 1T

Drug: D308 10mg Tab.; Drug: CKD-380 10mg Tab.

B group

EXPERIMENTAL

1. Period 1: CKD-380 10mg Tab. 1T 2. Period 2: D308 10mg Tab. 1T

Drug: D308 10mg Tab.; Drug: CKD-380 10mg Tab.

Interventions

D308 10mg Tab. DRUG

D308 10mg Tab.1T single oral administration under fasting condition

A group; B group

CKD-380 10mg Tab. DRUG

CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition

A group; B group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seunghoon Han, Professor

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 26, 2018
• Study Start: July 16, 2018
• Primary Completion: September 21, 2018
• Study Completion: November 9, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

KR (1)