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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189288
Other study ID # A99_03BE2122
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 14, 2022
Est. completion date April 15, 2022

Study information

Verified date January 2022
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 15, 2022
Est. primary completion date March 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
D418 Tab.
1T
CKD-388 Tab.
1T

Locations

Country Name City State
Korea, Republic of H plus Yangji hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCt of CKD-388, D418 Area under the CKD-388/D418 concentration in blood-time curve from zero to final 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
Primary Cmax of CKD-388, D418 The maximum CKD-388/D418 concentration in blood sampling time 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
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