Status:
COMPLETED
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension and Dyslipidemia
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386
Detailed Description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386 with co-administration of D013, D326, and D337 in h...
Eligibility Criteria
Inclusion
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥50kg (man) or 45kg (woman), 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 12-lead ECG results at screening.
- Those who agree to contraception during the participation of clinical trial.
- Individuals 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 before the first administration of investigational products.
- Those who donated whole blood or apheresis within 2 months or 1 month 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 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
- 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
- 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 study by investigators.
- Woman who are pregnant or breastfeeding.
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04694989
Start Date
February 20 2021
End Date
May 4 2021
Last Update
July 7 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea, 08779