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This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir Phosphate 75 mg capsules (Yangtze River) | Experimental | During the study session, healthy participants will be administered a single dose of Oseltamivir Phosphate capsules 75 mg of Yangtze River Pharmaceutical (Group) Co., Ltd., China under Fed condition. |
|
| Tamiflu capsules 75 mg (Genentech, Inc.) | Active Comparator | During the study session, healthy participants will be administered a single dose of Tamiflu capsules 75 mg of Genentech, Inc. under Fed condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir Phosphate 75 mg capsules | Drug | Capsules, 75 mg, single, oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) | Maximum measured concentration over the time span specified | 48 hours |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | The area under the concentration versus time curve, from time 0 to the last measurable concentration, where t = time of last measurable concentration, calculated using linear trapezoidal method | 48 hours |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) | The area under the concentration versus time curve from time 0 to infinity AUC0-∞ = AUC0-t + Clast/Kel; where Clast is last measurable concentration, Kel is elimination rate constant. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tejas Talati, MBBS | Veeda Clinical Research Pvt. Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austarpharma Llc | Edison | New Jersey | 08837 | United States |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Tamiflu capsules 75 mg | Drug | Capsules, 75 mg, single, oral dose |
|
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |