Status:
UNKNOWN
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
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 subjects of fifty-six (56), 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. Pha...
Eligibility Criteria
Inclusion
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- \* BMI = Weight(kg)/ Height(m)2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration
- Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail
Exclusion
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- Thiazolidinedione
- DPP-4 inhibitor
- Metformin
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Individuals with one of the following laboratory test results in screening
- AST, ALT \> UNL (upper normal limit) x 3
- Creatinine clearance ≤ 80 mL/min
- In ECG result, QTc \> 450 msec
- hCG(+) (only women)
- Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- Use of any prescription drugs within 14 days prior to study drug administration.
- Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
- History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
- Individuals who cannot eat standard meal provided from clinical trial center.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
- Individuals who had received a blood transfusion within 30 days prior to study drug administration.
- Exposure to any investigational drug within 6 months prior to the first IP administration.
- Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- Individuals who had consumed grapefruit juice \> 5cups/day or caffeine \> 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
- Individuals who had drinking (alcohol \> 30 g/day) within 30 days prior to the first IP administration or who cannot stop drinking.
- Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
- Pregnant or women who may be pregnant
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 18 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04676893
Start Date
February 26 2021
End Date
May 18 2021
Last Update
December 21 2020
Active Locations (1)
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1
Korea University Anam Hospital
Seoul, South Korea