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

Phase 1

• Conditions: Type II Diabetes
• Interventions: Drug: CKD-387; Drug: D484

• Registration Number: NCT03646799
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24
• Study Start: 2018-08-30
• Primary Completion: 2018-09-09
• Study Completion: 2018-09-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cmax 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	Maximum plasma concentration of Dapagliflozin
Cmax 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	Maximum plasma concentration of Metformin
AUClast 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	Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast 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	Area under the plasma concentration-time curve to last concentration of Metformin

Secondary Outcome Measures

Name	Time	Method
AUCinf 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	Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
AUCinf 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	Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
Tmax 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	Time to maximum plasma concentration of Dapagliflozin
Vd/F 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	Apparent volume of distribution of Dapagliflozin
CL/F 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	Apparent clearance of Metformin
T1/2 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	Half-life of Dapagliflozin
Tmax 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	Time to maximum plasma concentration of Metformin
T1/2 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	Half-life of Metformin
Vd/F 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	Apparent volume of distribution of Metformin
CL/F 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	Apparent clearance of Dapagliflozin

Trial Locations

Locations (1)

Yonsei University Severance Hospital; 🇰🇷 Soeul, Korea, Republic of