- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627207
A Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of CKD-333 or Co-administration of CKD-333 and D085 in Healthy Volunteers (CKD-333)
November 11, 2020 updated by: Chong Kun Dang Pharmaceutical
A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D085 in Healthy Volunteers Under Fasting Conditions
A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 in healthy volunteers
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A randomized, open, single-dose, 3 period partial replicated crossover-design clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of CKD-333 or co-administration of CKD-330 and D085 in healthy volunteers under fasting conditions
Study Type
Interventional
Enrollment (Anticipated)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hong Jang Hee, M.D.
- Phone Number: +82-42-280-6940
- Email: boniii@cnu.ac.kr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 54 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult volunteers aged 19≤ ~ <55-year-old.
- Those who have body weight ≥ 55kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 17.5 ≤ ~ < 30.5 kg/m2
- Those who have no congenital/chronic diseases, abnormal symptoms.
- Those who were deemed to eligible for participation of clinical trial by laboratory tests, vital signs and 12-lead ECG etc.
- Those who voluntarily decide to participate and agree to comply with the cautions and fully understanding the detailed description of this clinical trial.
- Those who consent to proper contraception during the study period and do not donate sperm until 14 days after the last administration of investigational product. And those who consent not to become pregnant or breastfeeding.
- Those who have ability and willingness to participate in clinical trial
Exclusion Criteria:
- Those who have medical history or medical symptom of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or mental disease.
- Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
Those who have the test results written below,
- AST or ALT are 2 times higher than upper normal range
- Creatinine is upper normal range or eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- QTc is higher than 450msec measured by 12-lead ECG
- CPK is 3 times higher than upper normal range
- Serum Potassium is higher than 5.5 mEq/L
- Hematocrit is under normal range
- Those who exceed alcohol consumption criteria (21 units/week within 3 months) prior to first administration of investigational product. Or Those who can't quit drinking alcohol from 48 hours to end of bleeding time point.
- Those who exceed smoke criteria (20 cigarettes/day within 6 months) prior to first administration of investigational product. Or Those who can't quit smoking during hospitalization.
- Those who have participated in other clinical trial and received Investigational product within 6 month prior to the first administration of drug.
Those who have the test results written below,
- Systolic blood pressure ≥140 mmHg or <90 mmHg
- Diastolic blood pressure ≥90 mmHg or <60 mmHg
- Those who have a drug abuse history within one year prior to first administration of investigational product or positive reaction on urine drug screening test.
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product.
Those who received following drugs, which may affect results of clinical trial and safety.
- Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of the investigational drug (especially Glecaprevir, Pibrentasvir).
- Those who donated whole blood within 2 months or apheresis within 1 month or received transfusion within 1 month.
- Those who have history of hypersensitivity to active pharmaceutical ingredient or Dihydropyridine or Aspirin, antibiotics etc.
Those who deemed to ineligible for participation of clinical trial,
- Patient with hyperkalemia
- Patients with hepatopathy
- Patients with hereditary angioedema, ACE inhibitors or angiotensin II receptor antagonists who have a history of angioedema
- Primary hyperaldosteronism
- Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
- Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
- Patients with Intravascular volume depletion
- Patients with diabetes or kidney failure
- Patients with renal artery stenosis
- Patients with muscle disease
- Patients with Hypothyroidism
- Patients with a history of muscle toxicity when using statins or fibrates
- Patients who have recently had a kidney transplant
- Patients with history of shock
- Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- Those who took caffeine or grapefruit within 3 months(5 cups/day) (before the first administration of investigational product) and can't stop taking caffeine or grapefruit until the end of clinical trial.
- Those who can't eat standard meal during hospitalization.
- Those who are pregnant or breastfeeding.
- Those who are deemed to ineligible for participation of clinical trial by investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reference-Reference-Test
Sequence 1
|
Other names: Reference
Other names: Test
|
Experimental: Reference-Test-Reference
Sequence 2
|
Other names: Reference
Other names: Test
|
Experimental: Test-Reference-Reference
Sequence 3
|
Other names: Reference
Other names: Test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt of CKD-330, D085, CKD-333
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
|
Area under the CKD-330/D085/CKD-333 concentration in blood-time curve from zero to final
|
Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
|
Cmax of CKD-330, D085, CKD-333
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
|
The maximum CKD-330/D085/CKD-333 concentration in blood sampling time t
|
Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hong Jang Hee, M.D., Chungnam National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 11, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 11, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A70_10BE2006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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