A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04703374
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: CKD-382(formulation I); Drug: CKD-382(formulation II); Drug: D026	Phase 1

Detailed Description

A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects
• Actual Study Start Date: Sep 25, 2020
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days
Experimental: B Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days
Experimental: C Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days
Experimental: D Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days
Experimental: E Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days
Experimental: F Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)	Drug: CKD-382(formulation I); 1 tablet administered under fasting condition for 7days; Drug: CKD-382(formulation II); 1 tablet administered under fasting condition for 7days; Drug: D026; 1 tablet administered under fasting condition for 7days

Outcome Measures

Primary Outcome Measures

1. AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose [0~24h]

2. Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor [Baseline versus Multiple dose during 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy adult

2. Body weight more than 50kg

3. Body Mass Index more than 18.0 and under 27.0

4. Who has negative result on Helicobacter Pylori antibody test

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.

2. Have a gastrointestinal disease history(including surgery) that can effect drug absorption

3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do	Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04703374
• Other Study ID Numbers: A105_01BE2010
• First Posted: Jan 11, 2021
• Last Update Posted: Jan 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chong Kun Dang Pharmaceutical: CKD-382; D026

Study Results

No Results Posted as of Jan 11, 2021