Status:
UNKNOWN
Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
19-54 years
Phase:
PHASE1
Brief Summary
This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
Detailed Description
To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Eligibility Criteria
Inclusion
- Healthy adults over the age of 19 years and under the age of 55 years at the time of screening
- Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
- \* BMI = Weight(kg)/ Height(m)2
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
- Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
- Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
- Individuals with the ability and willingness to participate the entire study period
Exclusion
- Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- Individuals with the following results at screening test:
- ALT or AST \> 2x the upper limit of the normal range
- Creatinine \> upper limit of the normal range or eGFR with MDRD \<60 ml/min/1.73 m2
- ECG Result, QTc \> 450msec
- CPK \> UNL(upper normal limit) x 3.0
- K \> 5.5mEq/l
- Hct \< lower limit of the normal range
- A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
- Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening or cannot quit smoking during hospitalization period
- Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
- Following vital signs results at screening
- Sitting systolic blood pressure ≥ 140 mmHg or \< 90 mmHg
- sitting diastolic blood pressure ≥90 mmHg or \<60 mmHg
- Individuals with a medical history of significant drug abuse within one year prior to the screening or positive for abuse drug in urine test results at screening
- Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
- Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
- Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
- Individuals with hypersensitivity to investigational products or the investigational products ingredients
- Patients or conditions deemed to be at risk for using investigational products
- Patient with hyperkalemia
- Patients with hepatopathy
- Patients with hereditary angioedema, ACE inhibitors or angiotensin 2 receptor antagonists who have a history of angioedema
- Primary hyperaldosteronism
- Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
- Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
- Patients with Intravascular volume depletion
- Patients with diabetes or kidney failure
- Patients with renal artery stenosis
- Patients with muscle disease
- Patients with Hypothyroidism
- Patients with a history of muscle toxicity when using statins or fibrates
- Patients who have recently had a kidney transplant
- Patients with history of shock
- Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to screening or cannot quit drinking during clinical trials period
- Individuals who cannot eat standard meal in institution
- Women who are pregnant or may be pregnant
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04478097
Start Date
July 14 2020
End Date
January 1 2021
Last Update
July 22 2020
Active Locations (1)
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1
Jang Hee Hong
Daejeon, South Korea