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

NCT03646799 | Unknown Phase 1

• 1 other identifier: 184BE18012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: CKD-387; Drug: D484

Group 2

EXPERIMENTAL

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

Drug: CKD-387; Drug: D484

Interventions

CKD-387 DRUG

test drug

Group 1; Group 2

D484 DRUG

reference drug

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Yonsei University Severance Hospital

Soeul, South Korea

RECRUITING

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

• Min Soo Park, Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Soo Park, Ph.D.

CONTACT

82-2-2228-0270; minspark@yuhs.ac

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: August 23, 2018
• First Posted: August 24, 2018
• Study Start: August 30, 2018
• Primary Completion: September 9, 2018
• Study Completion: September 14, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

KR (1)