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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04987970
Other study ID # A83_07BE2117
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 12, 2021
Est. completion date November 27, 2021

Study information

Verified date December 2021
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-386(2)


Description:

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386(2) with co-administration of D013, D326, and D337 in healthy adult volunteers


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 27, 2021
Est. primary completion date November 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
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 4 weeks. 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) - Heavy Smoking: 20 cigarettes/day 6. Patients with the following diseases - Patients with hypersensitivity to the main constituents or components of the investigational drug - Severe hepatic impairment, biliary atresia or cholestasis - Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists - Diabetes mellitus - Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2] - Renal vascular hypertension patients - Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit - Patients with myopathy or have a history of family or genetic history of myopathy - Hypothyroidism - If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs 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-386(2)
QD, PO
D013, D326, D337
QD, PO

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-386(2) Area under the concentration-time curve from time zero to time Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Primary Cmax of CKD-386(2) Maximum plasma concentration of the drug Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary AUCinf of CKD-386(2) Area under the concentration-time curve from zero up to 8 Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary Tmax of CKD-386(2) Time to maximum plasma concentration Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary AUCt/AUCinf of CKD-386(2) AUCt/AUCinf Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary T1/2 of CKD-386(2) Terminal elimination half-life Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
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