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

NCT04035538 | Unknown Phase 1

• 1 other identifier: A94_01BE1909
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Keywords

CKD-320

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

A group

EXPERIMENTAL

Drug: CKD-320, D012

B group

EXPERIMENTAL

Drug: CKD-320, D012

Interventions

CKD-320, D012 DRUG

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

A group; B group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult older than 19 years at the time of screening
• Body weight more than 55kg and within ±20% of the calculated ideal body weight(IBW = (height -100) x 0.9)
• No congenital or chronic disease and no pathological symptoms or findings
• Suitable subject who is determined to be suitable in laboratory testing such as hematology, blood chemistry, urinalysis and 12-lead electrocardiogram
• Subject who have received a detailed explanation of this clinical trial and have fully understood it, and agree in writing to comply

You may not qualify if:

• 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
• 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
• A hereditary angioedema patient, with a history angioedema, or hereditary fructose patient
• Clinical laboratory test results showing the following values
• ALT or AST \> 2 times upper limit of normal range
• eGFR \< 60mL/min/1.73m2
• Subject with a history of overreaction or clinical significant hypersensitivity to drugs
• Subject who has a systolic blood pressure \> 140mmHg or \< 100mmHg, diastolic blood pressure \> 90mmHg or \< 60mmHg, pulses ≥ 100 per minutes
• In case of past history of drug abuse or positive for urine test of drug abuse
• Those taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
• 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
• Those taking other clinical trial drugs or bioequivalence test drugs within 6months before the first administration of clinical trial drug
• 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
• 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)
• \> 10 smokers per day within 3months of screening and those who can't quit smoking

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jang-Hee Hong

CONTACT

+82-42-280-6940; boniii@cnu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 29, 2019

Record last verified: 2019-07