NCT06119958
Recruiting
Phase 1
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 site in 1 country32 target enrollmentOctober 27, 2023
Overview
- Phase
- Phase 1
- Intervention
- DWC202313
- Conditions
- Drug Drug Interaction
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Cmax,ss of DWC202313 and DWC202314
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is A two-arm, open-label, single-sequence, multiple oral dosings, crossover study to evaluate the safety and the pharmacokinetic interaction of DWC202313 and DWC202314 in healthy adult volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •over 19 year old
Exclusion Criteria
- •Galactose intolerance
- •Lapp lactase deficiency
Arms & Interventions
DWC202313
DWC202313
Intervention: DWC202313
DWC202314
DWC202314
Intervention: DWC202314
Outcomes
Primary Outcomes
Cmax,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
AUCt,ss of DWC202313 and DWC202314
Time Frame: Up to 14 days
Secondary Outcomes
- Tmax,ss of DWC202313 and DWC202314(Up to 14 days)
- Cmin,ss of DWC202313 and DWC202314(Up to 14 days)
- t1/2 of DWC202313 and DWC202314(Up to 14 days)
- CLss/F of DWC202313 and DWC202314(Up to 14 days)
- Vdss/F of DWC202313 and DWC202314(Up to 14 days)
- PTF of DWC202313 and DWC202314(Up to 14 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Safety/Tolerability and Pharmacokinetic Study of SID142Arterial Occlusive DiseasesNCT02625714SK Chemicals Co., Ltd.41
Completed
Phase 1
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.Type 2 Diabetes MellitusNCT06483243Chong Kun Dang Pharmaceutical45
Completed
Phase 1
Drug-drug Interaction Study Between UIC201603, and UIC201604HealthyNCT06568133Korea United Pharm. Inc.57
Completed
Phase 1
Drug-drug Interaction Study Between UIC201601 and UIC201602HealthyNCT05190133Korea United Pharm. Inc.40
Completed
Phase 1
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult VolunteersHealth, SubjectiveNCT05009368Celltrion41