Clinical trial NCT04768673: A Study to Investigate the PK and Safety of CKD-393
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes
Keywords: CKD-393
Type II Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Detailed description: A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Eligibility criteria: \[Inclusion Criteria\]

1. Between 19 aged and 50 aged healthy adult
2. Body weight more than 55kg for male, more than 50kg for female
3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
4. if female, the subject must satisfy more than one of the following:

   * subject who have reached menopause (no natural menstruation for at least 2 years.)
   * subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

\[Exclusion Criteria\]

1. Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
2. Subject with one of the following laboratory test results

   * AST, ALT \> UNLx1.5
   * eGRF \< 60 ml/min/1.73 m2 (MDRD formula)
   * immuno-serology test results in positive
   * Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg
3. Subject who has history of the following and the history may affect safety of the subject or result of this study

   * History of any prescription drug or herbal medicine within 14 days before first administration investigational products
   * History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
   * History of drug-metabolizing induction/inhibition enzyme such as barbital

Primary outcomes:
measure: Cmax
timeFrame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
measure: AUClast
timeFrame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary outcomes:
measure: AUCinf
timeFrame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
measure: Tmax
timeFrame: 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
measure: t1/2
timeFrame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
measure: Vd/F
timeFrame: 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
measure: CL/F
timeFrame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu,
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: