Comparative Bioavailability: Two Pramipexole Formulations in Healthy Volunteers after a Single Dose Administration under Fasting Conditions
Bibliographic record
Abstract
The study was performed to compare the bioavailability of two Pramipexole 0.125 mg tablet formulations: the test formulation was pramipezan (pramipexole) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmacutica Ltda * . Sifrol (Pramipexole) from Boehringer Ingelheim do Brasil Qumica e Farmacutica Ltda was used as reference formulation. The study was conducted open with randomized two period crossover design and 8 days wash out period in 48 volunteers of both sexes. Plasma samples were obtained over a 48 hour interval. Pramipexole was analyzed by LC-MS-MS in the presence of Tansulosina as internal standard. The mean ratio of parameters C max and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC 0-t for test and reference formulation were 8201.90 pg.h/mL and 7891.56 pg.h/mL, for AUC 0- were 8574.71 pg.h/mL and 8288.01 pg.h/mL and, for C max 642.09 pg/mL and 633.94 pg/mL, respectively. Geometric mean of pramipezan (pramipexole) /Sifrol 0.125 mg individual percent ratio was 103.61% AUC 0-t , 103.13% for AUC 0- and 100.81% for C max . The 90% confidence intervals were 98.02 -109.51%, 97.95 -108.59%, 93.06 -109.21%, respectively. Since the 90% confidence intervals for C max , AUC 0-t and AUC 0- were within the 80 -125% interval proposed by Food and Drug Administration, it was concluded that Pramipezan (pramipexole) 0.125 mg tablet was bioequivalent to Sifrol 0.125 mg tablet according to both the rate and extent of absorption.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".