Status:
COMPLETED
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(6)
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).
Eligibility Criteria
Inclusion
- Healthy adult volunteers aged ≥ 19 years.
- Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
- Those who meet the blood pressure criteria during screening tests:
- Systolic Blood Pressure: 90 to 139 mmHg
- Diastolic Blood Pressure: 60 to 89 mmHg
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
- Those who agree to contraception during the participation of clinical trial.
- Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
- Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
- Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1glass: Soju 50mL, Wine 30mL, or beer 250mL)
- Smoking: 20 cigarettes/day
- Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to Sunset yellow FCF.
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who are deemed insufficient to participate in this clinical trial by investigators.
- Woman who are pregnant or breastfeeding.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06112678
Start Date
January 4 2024
End Date
March 18 2024
Last Update
March 26 2024
Active Locations (1)
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1
H plus Yangji hospital
Seoul, South Korea