Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

NCT04952506 | Completed Phase 1

• 1 other identifier: A111_02PK2111P
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-349, D113

  Area under the CKD-349/D113 concentration in blood-time curve from zero to final

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

• Cmax of CKD-349, D113

  The maximum CKD-349/D113 concentration in blood sampling time t

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Study Arms (6)

R-T1-T2

EXPERIMENTAL

1. Period 1: Reference 2. Period 2: Test 1 3. Period 3: Test 2

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

T2-R-T1

EXPERIMENTAL

1. Period 1: Test 2 2. Period 2: Reference 3. Period 3: Test 1

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

T1-T2-R

EXPERIMENTAL

1. Period 1: Test 1 2. Period 2: Test 2 3. Period 3: Reference

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

T2-T1-R

EXPERIMENTAL

1. Period 1: Test 2 2. Period 2: Test 1 3. Period 3: Reference

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

T1-R-T2

EXPERIMENTAL

1. Period 1: Test 1 2. Period 2: Reference 3. Period 3: Test 2

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

R-T2-T1

EXPERIMENTAL

1. Period 1: Reference 2. Period 2: Test 2 3. Period 3: Test 1

Drug: CKD-349 F1 Tab.; Drug: CKD-349 F2 Tab.; Drug: D113 Tab.

Interventions

CKD-349 F1 Tab. DRUG

1T Single does

Also known as: Test 1

R-T1-T2; R-T2-T1; T1-R-T2; T1-T2-R; T2-R-T1; T2-T1-R

CKD-349 F2 Tab. DRUG

1T Single does

Also known as: Test 2

R-T1-T2; R-T2-T1; T1-R-T2; T1-T2-R; T2-R-T1; T2-T1-R

D113 Tab. DRUG

1T Single does

Also known as: Reference

R-T1-T2; R-T2-T1; T1-R-T2; T1-T2-R; T2-R-T1; T2-T1-R

Eligibility Criteria

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

You may qualify if:

• Healthy adults over the age of 19 years at the time of screening
• Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) \< 29.9kg/m2 and total body weight ≥ 55 kg
• \* BMI = Weight(kg)/ Height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
• In case of female subjects, those who were confirmed to be non-pregnant at screening
• Individuals who agreed to the use of appropriate medically recognized contraceptive methods themselves or their spouse (or partner) from the first administration of the investigational product to the 7th day of last administration. And in case of male subjects, those who agreed not donation of sperm, in case of female subjects, those who agreed not to be pregnant or breast-feeding from the first administration of the investigational product to the 7th day of last administration
• Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial.

You may not qualify if:

• Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
• Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
• Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
• Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
• Individuals with hypersensitivity to investigational products or the investigational products ingredients
• Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than 36hr after discontinuation.
• Individuals with history of vascular edema in angiotensin-converting enzyme(ACE) inhibitors or angiotensin receptor blocker(ARB) administration
• Individuals with genetic or idiopathic angioedema
• Individuals with liver cirrhosis or atresia of bile ducts or cholestasis
• Individuals with primary hyperaldosteronism
• Following vital signs results at screening
• Sitting systolic blood pressure \> 140 mmHg or \< 90 mmHg
• Sitting diastolic blood pressure \> 90 mmHg or \<60 mmHg
• Individuals with the following results at screening test:
• AST(GOT) or ALT(GPT) \> 2x the upper limit of the normal range

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jang Hee Hong

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

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: June 29, 2021
• First Posted: July 7, 2021
• Study Start: July 19, 2021
• Primary Completion: July 29, 2021
• Study Completion: August 20, 2021
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)