Overview

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(5)

Status:
Not yet recruiting
Trial end date:
2023-06-13
Target enrollment:
0
Participant gender:
All
Summary
A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(5).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Criteria
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years.

2. Body weight ≥55kg 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 ECG results at screening.

6. Those who agree to contraception during the participation of clinical trial.

7. Those 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 and those who take drug could affect to
clinical trial within 10 days 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 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 criteria write below within 1
month before the first administration of investigational products.

- Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine
30mL, or beer 250mL)

- Smoking: 20 cigarettes/day

6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction,
shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable
angina, hypothyroidism.

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 trial by
investigators.

9. Woman who are pregnant or breastfeeding.