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

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646799
• Other study ID #: 184BE18012
• Status: Recruiting
• Phase: Phase 1
• Start date: August 30, 2018
• Est. completion date: September 14, 2018

Study information

• Verified date: August 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: Min Soo Park, Ph.D.
• Phone: 82-2-2228-0270
• Email: minspark[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 14, 2018
• Est. primary completion date: September 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• CKD-387
test drug
• D484
reference drug

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Soeul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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