A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2)

Dyslipidemias Clinical Trial

Official title:

A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391(2) and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06088017
• Other study ID #: A52_11BE2309
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2023
• Est. completion date: January 22, 2024

Study information

• Verified date: October 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391(2)

Description:

A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391(2) and co-administration of CKD-331 and D337 in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 22, 2024
• Est. primary completion date: January 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

• Inclusion Criteria

1. Healthy adult aged between 19 to 55 at screening

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

3. Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings

4. Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening

5. Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial

6. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial

• Exclusion Criteria

1. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day

2. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol

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

4. Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks

5. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery

6. Patients with the following diseases

• Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit

• Patients with severe liver failure or biliary obstruction and bile congestion

• Patients with muscular disease, rhabdomyolysis, or persons with a past history

• Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs

• Patients with renal impairment or a history of in and patients with severe renal dysfunction

• Patients with a history of muscle toxicity to other statin drugs or fibrate drugs

7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

8. Those who have hypersensitivity to the main constituents or components of the investigational drug

9. Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests

10. Woman who are pregnant or breastfeeding

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• CKD-391(2)
QD, PO
• CKD-331, D337
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Bumin hopspital, Seoul	Seoul	Gangseo-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-391(2)	Area under the concentration-time curve time zero to time	Pre-dose(0 hour) to 72hours
Primary	Cmax of CKD-391(2)	Maximum plasma concentration of the drug	Pre-dose(0 hour) to 72hours