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

A 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

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

Study Overview

• Status: Unknown
• Conditions: Type II Diabetes
• Intervention / Treatment: Drug: D484; Drug: CKD-387

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Soo Park, Ph.D.; Phone Number: 82-2-2228-0270; Email: minspark@yuhs.ac

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Recruiting
    • Yonsei University Severance Hospital
    • Contact: Min Soo Park, Ph.D. M.D; Phone Number: +82 2 2228 0400; Email: minspark@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)	Drug: D484; reference drug; Drug: CKD-387; test drug
Experimental: Group 2; Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)	Drug: D484; reference drug; Drug: CKD-387; test drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Dapagliflozin	Maximum plasma concentration of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Cmax of Metformin	Maximum plasma concentration of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Dapagliflozin	Area under the plasma concentration-time curve to last concentration of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUClast of Metformin	Area under the plasma concentration-time curve to last concentration of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of Dapagliflozin	Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
AUCinf of Metformin	Area under the plasma concentration-time curve from zero to infinity concentration of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Dapagliflozin	Time to maximum plasma concentration of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Tmax of Metformin	Time to maximum plasma concentration of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Dapagliflozin	Half-life of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
T1/2 of Metformin	Half-life of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Dapagliflozin	Apparent volume of distribution of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Vd/F of Metformin	Apparent volume of distribution of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Dapagliflozin	Apparent clearance of Dapagliflozin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
CL/F of Metformin	Apparent clearance of Metformin	Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Soo Park, Ph.D., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2018
• Primary Completion (Anticipated): September 9, 2018
• Study Completion (Anticipated): September 14, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 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: 184BE18012

Drug and device information, study documents

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