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| ID | Type | Description | Link |
|---|---|---|---|
| STPh40/09 |
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To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The formulations' comparative bioavailability after oral administration will be assessed based on the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured by a proper and validated analytical method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lincomycin - Active Comparative - Hard Gelatin Capsule | Active Comparator |
| |
| Lincomycin - Study Drug - Hard Gelatin Capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lincomycin | Drug | Single Dose Hard Gelatin Capsule - oral - 500 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC [0-t]Area under the curve of concentration vs. time, from time 0 (zero) up to the time of the last observed concentration above the limit of quantification, calculated by the trapezium rules. | 1 week | |
| Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time; | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| AUC [0-¥]Area under the curve of drug concentration versus time, from time 0 (zero) extrapolated to the infinite, calculated as AUC [0-¥] = AUC [0-t] + Ct/Ke, in which Ct is the last concentration determined above the limit of | 1 week | |
| quantification. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Campinas | São Paulo | 13012-000 | Brazil | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008034 | Lincomycin |
| ID | Term |
|---|---|
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lincomycin | Drug | Single Dose Hard Gelatin Capsule - oral - 500 mg |
|
|
| 1 week |
| Ke Terminal First Order Elimination Constant, estimated by the angular coefficient of the linear regression, calculated by the Least Square Method, from the natural logarithms of concentration vs. time to the last four values of concentration (or at | 1 week |
| least three) above the limit of quantification. | 1 week |
| T½ Half-life time, calculated as ln (2) / Ke. | 1 week |
| Adverse events and vital signs. | 1 week |
| Campinas |
| São Paulo |
| 13012-431 |
| Brazil |
| D006027 |
| Glycosides |
| D002241 | Carbohydrates |