Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04819932
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Anticipated Duration (Days): 20
• Patients Per Site Per Month: 97.4

Study Details

Study Description

Brief Summary

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWJ1451	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers
• Actual Study Start Date: Mar 13, 2021
• Actual Primary Completion Date: Mar 13, 2021
• Anticipated Study Completion Date: Apr 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group1 subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition	Drug: DWJ1451; DWC202008 DWC202009
Experimental: group2 subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition	Drug: DWJ1451; DWC202008 DWC202009

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameter of DWJ1451:AUC0-t [0 - 72 hours after dosing]

   Area under the plasma xonxentration-time curve from time 0 to t

2. Pharmacokinetic parameter of DWJ1451:Cmax [0 - 72 hours after dosing]

   Maximum plasma drug concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 19 to 55 years

• Healthy Adult

Exclusion Criteria:

• Non-Healthy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	54907

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT04819932
• Other Study ID Numbers: DW_DWJ1451102
• First Posted: Mar 29, 2021
• Last Update Posted: Mar 29, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 29, 2021