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Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Propofol solution (1% [10 mg/mL]), via intravenous injection |
|
| Reference product | Active Comparator | Propofol emulsion (1% [10 mg/mL]), via intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cudafol(R) (propofol, 1% [10 mg/mL]) | Drug | Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on pharmacokinetic parameter: Area Under Curve | 0-24 hours post dose | |
| Bioequivalence based on pharmacokinetic parameter: Cmax | 0-24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Tmax | 0-24 hours post dose | |
| Incidence of adverse events and tolerability | Number of adverse events and local tolerability | 7 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Diprivan(R) (propofol, 1% [10 mg/mL]) | Drug | Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |