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An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects
26 healthy subjects will be randomized to one of the 2 groups in the same ratio.
"YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15
"YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group 1 | Experimental | 13 subjects, Cross-over, Single dose of YHR2402 on day 1, Co-Administration of YHR2402 and YHR2403 on day 15 |
|
| Sequence Group 2 | Experimental | 13 subjects, Cross-over, Co-Administration of YHR2402 and YHR2403 on day 1, Single dose of YHR2402 on day 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHR2402 | Drug | Test Drug: YHR2402 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine | 0-96 hours |
| Maximum plasma concentration [Cmax] | of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine | 0-96 hours |
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | South Korea |
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two-way crossover
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| YHR2402+YHR2403 |
| Drug |
Test Drug: YHR2402+YHR2403 |
|
of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine |
| 0-96 hours |
| Time of Maximum observed plasma concentration [Tmax] | of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine | 0-96 hours |
| Apparent Terminal Elimination Half-life [t1/2] | of Chlorpheniramine, Dihydrocodeine and Dl-Methylephedrine | 0-96 hours |