An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- YHP2406
- Conditions
- Not specified
- Sponsor
- Yuhan Corporation
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Area under the plasma drug concentration-time curve [AUCt]
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
Detailed Description
62 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 18-30 kg/m2
- •Those without clinically significant congenital or chronic diseases
Exclusion Criteria
- •Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
- •Others who are judged ineligible to participate in the trial by the principal investigator.
- •Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Arms & Interventions
A(RT)
31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
Intervention: YHP2406
A(RT)
31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
Intervention: YHR2501
B(TR)
31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
Intervention: YHP2406
B(TR)
31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
Intervention: YHR2501
Outcomes
Primary Outcomes
Area under the plasma drug concentration-time curve [AUCt]
Time Frame: 0-8 hours
Area under the plasma drug concentration-time curve \[AUCt\] of Amoxicillin \& Clavulanic acid
Maximum plasma concentration [Cmax]
Time Frame: 0-8 hours
Maximum plasma concentration \[Cmax\] of Amoxicillin \& Clavulanic acid
Secondary Outcomes
- Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf](0-8 Hours)
- Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf](0-8 Hours)
- Time of peak concentration [Tmax](0-8 Hours)
- Terminal phase of half-life [t1/2](0-8 Hours)