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

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Type II Diabetes

Treatments: Drug: CKD-387; Drug: D484

Study type: Interventional

Funder types: Industry

Identifiers

NCT03646799

184BE18012

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: D484

Drug: CKD-387

Group 2

Experimental group

Description:

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

Treatment:

Drug: D484

Drug: CKD-387