Clinical trial NCT04694989: A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)
Official title: 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 Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension and Dyslipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 healthy adult volunteers

Eligibility criteria: 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 2 months or 1 month 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. 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.

Primary outcomes:
measure: AUCt of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
measure: Cmax of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Secondary outcomes:
measure: AUCinf of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
measure: Tmax of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
measure: AUCt/AUCinf of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
measure: T1/2 of CKD-386
timeFrame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Gwanak-gu
Study officials:
affiliation: H Plus Yangji Hospital
name: Yook-Hwan Noh, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: