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Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388(2) in Healthy Subjects

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05189288
Collaborator
(none)
60
Enrollment
2
Arms
1.2
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: D418 Tab.
  • Drug: CKD-388 Tab.
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
Anticipated Study Start Date :
Feb 11, 2022
Anticipated Primary Completion Date :
Mar 12, 2022
Anticipated Study Completion Date :
Mar 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reference-Test

D418 Tab. - CKD-388 Tab.

Drug: D418 Tab.
1T
Other Names:
  • Reference

    • Drug: CKD-388 Tab.
    1T
    Other Names:
  • Test

    		•
    Experimental: Test-Reference

    CKD-388 Tab. - D418 Tab.

    Drug: D418 Tab.
    1T
    Other Names:
  • Reference

    • Drug: CKD-388 Tab.
    1T
    Other Names:
  • Test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCt of CKD-388, D418 [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]

      Area under the CKD-388/D418 concentration in blood-time curve from zero to final

    2. Cmax of CKD-388, D418 [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]

      The maximum CKD-388/D418 concentration in blood sampling time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    1. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.

    2. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

    3. Those who agree to contraception during the participation of clinical trial.

    4. 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
    1. 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

    1. 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

    2. In the case of female volunteers, those who are pregnant or suspected of being pregnant or are lactating

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Jaewoo Kim, South Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05189288
    Other Study ID Numbers:
    • A99_03BE2122
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis B, Chronic

    Study Results

    No Results Posted as of Jan 12, 2022