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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05192356
Other study ID # A86_10BE2121
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 23, 2022
Est. completion date June 8, 2022

Study information

Verified date June 2023
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(3)


Description:

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348(3) with coadministration of CKD-828, D097 and D337 in healthy adult volunteers


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date June 8, 2022
Est. primary completion date May 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: 1. Healthy adult volunteers aged = 19 years 2. Weight =50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 3. Those who meet the blood pressure criteria during screening tests: - Systolic Blood Pressure: 90 to 139 mmHg - Diastolic Blood Pressure: 60 to 89 mmHg 4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening. 6. Those who agree to contraception during the participation of clinical trial. 7. 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 who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products. 3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. Those who exceed an alcohol and cigarette consumption than below criteria - Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) - Smoking: 20 cigarettes/day 6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. 7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. 8. Those who are deemed insufficient to participate in this clinical study by investigators. 9. Woman who are pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CKD-348(3)
QD, PO
CKD-828, D097, D337
QD, PO

Locations

Country Name City State
Korea, Republic of H Plus Yangji Hospital Seoul Gwanak-gu

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-348(3) AUCt: Area under the concentration-time curve from time zero to time Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Primary Cmax of CKD-348(3) Cmax: Maximum plasma concentration of the drug Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
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