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

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ClinicalTrials.gov Identifier: NCT03646799
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: CKD-387 Drug: D484 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 9, 2018
Estimated Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine


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

Drug: D484
reference drug

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

Drug: D484
reference drug




Primary Outcome Measures :
  1. Cmax of Dapagliflozin [ Time Frame: 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

  2. Cmax of Metformin [ Time Frame: 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

  3. AUClast of Dapagliflozin [ Time Frame: 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

  4. AUClast of Metformin [ Time Frame: 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 :
  1. AUCinf of Dapagliflozin [ Time Frame: 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

  2. AUCinf of Metformin [ Time Frame: 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

  3. Tmax of Dapagliflozin [ Time Frame: 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

  4. Tmax of Metformin [ Time Frame: 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

  5. T1/2 of Dapagliflozin [ Time Frame: 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

  6. T1/2 of Metformin [ Time Frame: 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

  7. Vd/F of Dapagliflozin [ Time Frame: 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

  8. Vd/F of Metformin [ Time Frame: 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

  9. CL/F of Dapagliflozin [ Time Frame: 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

  10. CL/F of Metformin [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646799


Contacts
Contact: Min Soo Park, Ph.D. 82-2-2228-0270 minspark@yuhs.ac

Locations
Korea, Republic of
Yonsei University Severance Hospital Recruiting
Soeul, Korea, Republic of
Contact: Min Soo Park, Ph.D. M.D    +82 2 2228 0400    minspark@yuhs.ac   
Principal Investigator: Min Soo Park, Ph.D. M.D         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Min Soo Park, Ph.D. Severance Hospital

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03646799     History of Changes
Other Study ID Numbers: 184BE18012
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases