Clinical trial NCT05189288: Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis b
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects

Detailed description: To healthy 60 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers, aged ≥ 19 years old at the time of screening.
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 at the time of screening.

   \* BMI = Weight(kg)/ Height(m)2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those with clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and urogenesis system, mental/nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
4. Those who have participated in other clinical trials or bioequivalence studies within 6 months of the first administration date and administered the investigational drug
5. Those who donated whole blood within 8 weeks of the first dose, or donated component blood within 2 weeks, or received blood transfusion within 4 weeks
6. Those who meet the following conditions within 1 month of the first administration date

   * In the case of men, alcohol consumption in excess of 21 drinks/week on average
   * For women, alcohol consumption in excess of 14 drinks/week on average

     (1 glass = 50 mL of soju or 30 mL of Western liquor or 250 mL of beer)
   * Smoking in excess of 20 cigarettes per day on average
7. A person who falls under any of the following

   * Patients with hypersensitivity to this drug or any of its components
   * Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Persons who are judged unsuitable for participation in this clinical trial by the principal investigator (or the authorized study doctor) for reasons other than the above selection/exclusion criteria
9. In the case of female volunteers, those who are pregnant or suspected of being pregnant or are lactating

Primary outcomes:
measure: AUCt of CKD-388, D418
timeFrame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
measure: Cmax of CKD-388, D418
timeFrame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H plus Yangji hospital
Study officials:
affiliation: South Korea
name: Jaewoo Kim
role: PRINCIPAL_INVESTIGATOR
References: