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
Not provided
Not provided
Not provided
Not provided
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CES1 gene variant group | Experimental | Oseltamivir 75 mg 1 cap |
|
| CES1 gene wild type group | Experimental | Oseltamivir 75 mg 1 cap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir 75 mg 1 cap | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Oseltamivir pharmacokinetic parameters | Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf) | Up to 0 to 48 h post dose |
| Oseltamivir carboxylate pharmacokinetic parameters | Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf) | Up to 0 to 48 h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Other oseltamivir pharmacokinetic parameters | first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio | Up to 0 to 48 h post dose |
| Other oseltamivir carboxylate pharmacokinetic parameters |
Not provided
Inclusion Criteria:
Healthy subjects:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyoung Soo Lim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | 110-768 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28437488 | Derived | Oh J, Lee S, Lee H, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS One. 2017 Apr 24;12(4):e0176320. doi: 10.1371/journal.pone.0176320. eCollection 2017. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio |
| Up to 0 to 48 h post dose |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |