A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

Hypertension Clinical Trial

— CKD-348  

Official title:

Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258865
• Other study ID #: A86_05BE1916P
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2020
• Est. completion date: May 13, 2020

Study information

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

Clinical Trial Summary

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Description:

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 13, 2020
• Est. primary completion date: April 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy adult volunteers aged = 19-year-old

2. Weight = 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2

3. Those who are eligible for adequate 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 chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings

5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests

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 hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug

2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug

3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month

4. Those who has a history of gastrointestinal surgery (

5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day

6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency

7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

9. Women who are pregnant or who may be pregnant and breastfeed

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• CKD-348 F1
QD, PO
• CKD-348 F2
QD, PO
• CKD-828, D097, D337
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul	Gwanak-gu

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-348	AUCt: Area under the concentration-time curve from time zero to time	Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Primary	Cmax of CKD-348	Cmax: Maximum plasma concentration of the drug	Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary	AUCinf of CKD-348	AUCinf: Area under the concentration-time curve from zero up to 8	Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary	Tmax of CKD-348	Tmax: Time to maximum plasma concentration	Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary	t1/2 of CKD-348	t1/2: Terminal elimination half-life	Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary	AUCt/AUCinf of CKD-348	AUCt/AUCinf	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours