Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults

NCT ID: NCT03646799

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2018-09-14

Brief Summary

Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults

Conditions

Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)

Group Type: EXPERIMENTAL

CKD-387

Intervention Type: DRUG

test drug

D484

Intervention Type: DRUG

reference drug

Group 2

Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)

Group Type: EXPERIMENTAL

CKD-387

Intervention Type: DRUG

test drug

D484

Intervention Type: DRUG

reference drug

Interventions

CKD-387

test drug

Intervention Type: DRUG

D484

reference drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers between the ages of 19 and 55
• Body weight ≥ 55kg for male, ≥ 50kg for female
• Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2
• Females who are post-menopausal or underwent sterilization
• Males who agreed to practice contraception until after 28 days of last intake Investigational product
• Ability to provide written informed consent

Exclusion Criteria

• Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
• Subject who are weak in dehydration or clinically significant dehydration
• IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
• Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
• Hypersensitive to dapagliflozin/metformin
• At screening,

• AST(Aspartate Transaminase), ALT(Alanine Transaminase) > UNL(upper normal limit)*1.25
• Total Bilirubin > UNL(upper normal limit)*1.5, CPK > UNL(upper normal limit)*1.5
• eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
• Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
• SBP(Systolic blood pressure) ≥ 150 mmHg or < 90 mmHg, DBP(Diastolic blood pressure) > 100 mmHg or < 50 mmHg
• History of drug abuse or positive urine drug screening results
• Women with pregnant, breast-feeding
• Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoker > 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
• Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
• Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
• Subject with whole blood donation within 60 days or component blood donation within 30 days
• Not eligible to participate for the study at the discretion of Investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Soo Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei University Severance Hospital

Soeul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Soo Park, Ph.D.

Role: CONTACT

minspark@yuhs.ac

82-2-2228-0270

Facility Contacts

Min Soo Park, Ph.D. M.D

Role: primary

minspark@yuhs.ac

+82 2 2228 0400

Other Identifiers

184BE18012

Identifier Type: -

Identifier Source: org_study_id