A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Co-administration of DWC20155 and DWC20156
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax)
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI≥18.5 and ≤27.0 kg/m2
- •No clinically significant findings
- •Age 19-55 years at screening
Exclusion Criteria
- •Who has allergy to investigational product
Arms & Interventions
Test/Reference Drug
DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
Intervention: Co-administration of DWC20155 and DWC20156
Test/Reference Drug
DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.
Intervention: DWJ1386 Tab.
Reference/Test Drug
co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
Intervention: Co-administration of DWC20155 and DWC20156
Reference/Test Drug
co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.
Intervention: DWJ1386 Tab.
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax)
Time Frame: 0-24 hours
Area under the plasma concentration versus time curve (AUC)
Time Frame: 0-24 hours