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This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 tablet formulation containing Levodopa 250 mg and Carbidopa 25 mg. The study will be performed at a single site with 44 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of Oseltamivir Phosphate 75 mg of 1 capsule formulations with Oseltamivir Phosphate 75 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa and Carbidopa Test Product | Experimental | Participants will receive one tablet of the test formulation containing Levodopa and Carbidopa 250 mg/ 25 mg. The tablet will be taken with water and in a fasting condition. |
|
| Levodopa and Carbidopa Referent Product | Experimental | Participants will receive one tablet of the marketed reference containing Levodopa and Carbidopa 250 mg/ 25 mg. The tablet will be taken with water and in a fasting condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa 250mg and Carbidopa 25mg Test Drug tablet | Drug | Investigational Medicinal Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Levodopa and Carbidopa: area under the plasma concentration-time curve from 0 to time t (AUC0-t) | 23 samples up to 10 hours will be taken after the administration in each period | |
| Total Levodopa and Carbidopa: area under the plasma concentration-time curve from 0 to time t (AUC0-∞) | 23 samples up to 10 hours will be taken after the administration in each period | |
| Total Levodopa and Carbidopa: Maximum plasma concentration (Cmax) | 23 samples up to 10 hours will be taken after the administration in each period | |
| Total Levodopa and Carbidopa: Time to achieve maximum plasma concentration (tmax) | 23 samples up to 10 hours will be taken after the administration in each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azidus Laboratories Ltd. | Chennai | Tamil Nadu | 600048 | India |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| D002230 | Carbidopa |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Levodopa 250mg and Carbidopa 25mg Referent Product tablet | Drug | Sinemet (Savio Industrial S.R.L, Brazil) |
|
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |