Overview

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)

Status:
Completed
Trial end date:
2019-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a randomized, open-label, fasting, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Criteria
Inclusion Criteria

1. Healthy adult aged over 19 at the time of screening

2. Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight
≥ 55 kg

# BMI=Weight(kg) / Height(m)²

3. Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis
based on a medical examination within the last 3 years

4. Subject who were deemed to be appropriate as study subjects in accordance with the
screening results (laboratory tests, vital signs, ECG etc.)

5. Subject who signed an informed consent form approved by the Institutional Review
Board(IRB) of Chonbuk National University Hospital and decided to participate in the
study after being fully informed of the study prior to participation, including the
objective, content and characteristics of the investigational drug

6. Subject who must consent to the use of reliable contraception and not to donate sperm,
from the 1st administration of the investigational product until 1 month after the
last administration of investigational product

7. Subject with the ability and willingness to participate during the study period

Exclusion Criteria

1. Subject who has medical evidence or history of clinically significant hematological,
renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic,
psychiatric, neurologic or allergic diseases

2. Subject with a medical history of gastrointestinal disorders(esophageal achalasia or
esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple
appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect
the absorption of drug

3. Subject who shows the following values as a result of laboratory tests

*Alanine Transaminase(ALT) or Aspartate Transaminase(AST) > 2 times upper limit of
normal range

4. Subject who has a history of regular alcohol consumption in excess of 210 g/week
within 6 months prior to screening

5. Subject who smokes more than 20 cigarettes a day within 6 months prior to screening

6. Subject who took other clinical trial drugs or bioequivalence test drugs within 6
months before the first administration of clinical trial drug

7. Subject who conform to the specific items below

- systolic blood pressure less than 90 mmHg, not less than 140 mmHg or diastolic
blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position

- Severe bradycardia (less than 50 beats/minute)

8. Subject who has a medical history of significant alcohol abuse or drug abuse within
one year prior to screening

9. Subject who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of
drug-metabolizing enzymes within 30 days prior to the first administration of
investigational product(s).

10. Subject who uses any of other drugs, including over-the-counter medications and
prescription medications within 10 days prior to first administration of
investigational product(s).

11. Subject who donated whole blood within 2 months, or blood components within 1 month
prior to first administration of investigational product(s).

12. Subject who has hypersensitivity to investigational product(s) or investigational
product(s) ingredient.

13. Subject who were deemed to be inappropriate to participate in the study by the
investigator.