Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

Cardiovascular Diseases Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04651881
• Other study ID #: A88_09BE2016P
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: October 27, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: November 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

Description:

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy adult aged more than 19 at the time of screening

2. Those who had 18.0kg/m² = Body Mass Index (BMI) < 30.0kg/m²

# BMI=Weight(kg) / Height(m)²

3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.

4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.

5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.

6. Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).

2. Those 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. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.

4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.

5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.

6. Those who have taken any drugs that may affect the clinical trial within 10 days.

7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.

8. Those who is unable to consume a high-fat meal provided during the study.

9. Those who are deemed insufficient to participate in this clinical study by investigators.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Reference drug
1 Cap., single oral administration under fed condition
• Test drug 1
1 Tab., single oral administration under fed condition
• Test drug 2
1 Tab., single oral administration under fed condition

Locations

Country	Name	City	State
Korea, Republic of	Central Hospital	Gyeonggi-do	Siheung-si

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of CKD-385	Area under the concentration-time curve from time zero to time of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Primary	Cmax of CKD-385	Maximum plasma concentration of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary	AUCinf of CKD-385	Area under the concentration-time curve from zero up to infinity of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary	Tmax of CKD-385	Time to maximum plasma concentration of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary	T1/2 of CKD-385	Terminal elimination half-life of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary	CL/F of CKD-385	Apparent clearance of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary	Vd/F of CKD-385	Apparent Volume of Distribution of CKD-385	Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours