Overview

Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

Status:
Not yet recruiting
Trial end date:
2021-08-16
Target enrollment:
0
Participant gender:
All
Summary
This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Criteria
Inclusion Criteria:

1. Healthy adults over the age of 19 years at the time of screening

2. Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9kg/m2 and total body
weight ≥ 55 kg

* BMI = Weight(kg)/ Height(m)2

3. Individuals without congenital/chronic diseases and without abnormal symptoms or
diagnosis based on a medical examination

4. 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 within 28 days to the scheduled date of first administration
of the investigational product

5. In case of female subjects, those who were confirmed to be non-pregnant at screening

6. Individuals who agreed to the use of appropriate medically recognized contraceptive
methods themselves or their spouse (or partner) from the first administration of the
investigational product to the 7th day of last administration. And in case of male
subjects, those who agreed not donation of sperm, in case of female subjects, those
who agreed not to be pregnant or breast-feeding from the first administration of the
investigational product to the 7th day of last administration

7. Individuals who voluntary decide to participate and agrees in writing to comply with
the precautions after hearing and fully understanding the detailed explanation of this
clinical trial.

Exclusion Criteria:

1. Individuals with a medical evidence or a history of clinically significant
hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology,
urinary, cardiovascular, musculoskeletal or psychiatric

2. Individuals with symptoms of acute disease within 28 days prior to the scheduled date
of first administration of the investigational product

3. 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

4. Individuals with a medical history or current symptoms that fall under one or more of
the following who are judged to be concerned about the use of investigational product

- Individuals with hypersensitivity to investigational products or the
investigational products ingredients

- Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than
36hr after discontinuation.

- Individuals with history of vascular edema in angiotensin-converting enzyme(ACE)
inhibitors or angiotensin receptor blocker(ARB) administration

- Individuals with genetic or idiopathic angioedema

- Individuals with liver cirrhosis or atresia of bile ducts or cholestasis

- Individuals with primary hyperaldosteronism

5. Following vital signs results at screening

- Sitting systolic blood pressure > 140 mmHg or < 90 mmHg

- Sitting diastolic blood pressure > 90 mmHg or <60 mmHg

6. Individuals with the following results at screening test:

- AST(GOT) or ALT(GPT) > 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

- K > 5.5mEq/l

- Positive reaction on serum test(PRP Ab, anti HIV(AIDS), HBs Ag, HCV Ab)

7. Individuals with a medical history of significant drug abuse or positive for abuse
drug in urine test results at screening

8. Individuals who had taken ethical(ETC) or over the counter(OTC) within the 10 days
prior to the first dose of investigational product

9. Individuals who donated whole blood within the 8 weeks, or donated blood components
within 4 weeks prior to the first dose of the investigational product or received a
blood transfusion with 4 weeks

10. 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

11. Individuals taking medication known to significantly induce or inhibit drug
metabolizing enzymes within 1 month before the first administration of clinical trial
drug

12. Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3
months prior to first dose of this study or cannot quit drinking during clinical
trials period

13. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1
unit = 10 g = 12.5 ml of pure alcohol) 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)

14. Individuals who exceed the smoking amount of 10 cigarettes per day within 3 months
prior to first dose of this study or cannot quit smoking during clinical trials period

15. Individuals who cannot eat standard meal in institution

16. Individuals who were deemed to be inappropriate to participate in the study by the
investigator