Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the drug-drug interaction between aceclofena and esomeprazole
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drug interaction between Aceclofenac 200 mg and Esomeprazole 20 mg in healthy male volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Aceclofenac → Esomeprazole → Concomitant of Aceclofenac and esomeprazole |
|
| Group 2 | Experimental | Concomitant of Aceclofenac and esomeprazole→Aceclofenac→ Esomeprazole |
|
| Group 3 | Experimental | Esomeprazole →Concomitant of Aceclofenac and esomeprazole→ Aceclofenac |
|
| Group 4 | Experimental | Concomitant of Aceclofenac and esomeprazole→Esomeprazole→Aceclofenac |
|
| Group 5 | Experimental | Esomeprazole→Aceclofenac→ Concomitant of Aceclofenac and esomeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aceclofenac | Drug | Oral single dose administration of aceclofenac 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of aceclofenac and esomeprazole in plasma | up to 24hours |
| AUClast | Area under the plasma concentration versus time curve to last time of aceclofenac and esomeprazole in plasma | up to 24hours |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 | Terminal half-time of aceclofenac and esomeprazole in plasma | up to 24hours |
| Tmax | Time to reach Cmax of aceclofenac and esomeprazole in plasma |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, PhD | Chonbuk National University Hospital in Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital. | Jeonju | Jeollabuk-do | 561-712 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C056498 | aceclofenac |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Group 6 | Experimental | Aceclofenac→Concomitant of Aceclofenac and esomeprazole→Esomeprazole |
|
|
| Esomeprazole | Drug | Oral single dose administration of aceclofenac 200mg |
|
|
| Aceclofenac and Esomeprazole | Drug | Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant |
|
|
| up to 24hours |
| CL/F | Apparent clearance of aceclofenac and esomeprazole | up to 24hours |
| Vd/F | Apparent volume of distribution of aceclofenac and esomeprazole | up to 24hours |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |