A Clinical Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012

Hypertension Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Replicate-crossover Study to Compare the Safety and Pharmacokinetics of CKD-320 and D012 in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035538
• Other study ID #: A94_01BE1909
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2019
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: Jang-Hee Hong
• Phone: +82-42-280-6940
• Email: boniii[@]cnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical study to compare the safety and pharmacokinetics of CKD-320 and D012

Description:

A randomized, open-label, single-dose, replicate-crossover study to compare the safety and pharmacokinetics of CKD-320 and D012 in healthy subjects

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy adult older than 19 years at the time of screening

2. Body weight more than 55kg and within ±20% of the calculated ideal body weight(IBW = (height -100) x 0.9)

3. No congenital or chronic disease and no pathological symptoms or findings

4. Suitable subject who is determined to be suitable in laboratory testing such as hematology, blood chemistry, urinalysis and 12-lead electrocardiogram

5. Subject who have received a detailed explanation of this clinical trial and have fully understood it, and agree in writing to comply

Exclusion Criteria:

1. Subject who has a history of clinical significant hepatobiliary, kidney, digestive, respiratory, blood-oncology, endocrine, urinary, psychiatric, musculoskeletal, immune, acute and unstable heart failure or evidence

2. Subject with a history of gastrointestinal disorders(Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery) that may affect the absorption

3. A hereditary angioedema patient, with a history angioedema, or hereditary fructose patient

4. Clinical laboratory test results showing the following values

• ALT or AST > 2 times upper limit of normal range

• eGFR < 60mL/min/1.73m2

5. Subject with a history of overreaction or clinical significant hypersensitivity to drugs

6. Subject who has a systolic blood pressure > 140mmHg or < 100mmHg, diastolic blood pressure > 90mmHg or < 60mmHg, pulses = 100 per minutes

7. In case of past history of drug abuse or positive for urine test of drug abuse

8. Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug

9. Those taking prescription drugs, natural drug(ex, St. John's wort), herbal medicine within 14days and non-prescription drugs or vitamin supplements within 7days before the first administration of clinical trial drug

10. Those taking other clinical trial drugs or bioequivalence test drugs within 6months before the first administration of clinical trial drug

11. Those who donated whole blood within 2 months or those who donated the components within 1 month or blood transfusion within 1 month before the first administration of the clinical trial drug

12. Subject who has a history of regular alcohol consumption exceeding 210g/week within 6months of screening (1 glass of beer(5%)=10g, 1 glass of soju(20%)=8g, 1 glass of wine(12%)=12g)

13. > 10 smokers per day within 3months of screening and those who can't quit smoking

14. Blood test(RPR Ab, HBS Ag, HCV Ab, anti HIV(AIDS)) results indicate a positive

15. Subject who can't comply with the lifestyle guidelines

16. A pregnant(a likely), breastfeeding women

17. Subject who don't agree or can't comply reliable contraception from screening to 14days after the last drug administration

18. Subject who is judged by the investigator principal to be ineligible to participate in the clinical trial

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• CKD-320, D012
R: D012 1tablet, QD, PO T: CKD-320 2tablets, QD, PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Primary	Cmax of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary	Tmax of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary	t1/2 of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary	AUCinf of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours
Secondary	AUCt/AUCinf of CKD-320		predose(0 hour), 0.17, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours