Bioequivalence study of Rosuvastatin in healthy volunteers after a single dose on an empty stomach
Bibliographic record
Abstract
Aim . To assess comparative pharmacokinetics and establish bioequivalence of film-coated Rosuvastatin 20 mg (OOO NTFF "POLYSAN", Russia) (T) and film-coated Crestor® 20 mg (AstraZeneca UK Limited, UK) (R) after a single dose of 20 mg on an empty stomach in healthy volunteers, as well as to study their safety and tolerability. Material and methods . This open-label, randomized, crossover, two-period study of comparative pharmacokinetics and bioequivalence of T and R following a single dose in the fasted state was conducted in 46 healthy volunteers at a single center. After randomization, volunteers in each Study Period received a single 20 mg rosuvastatin dose in a different sequence (TR or RT). Periods I and II were separated by a 14-day washout period. Plasma rosuvastatin concentrations were determined by high-liquid chromatography–mass spectrometry. Following pharmacokinetic parameters were calculated: area under the concentration-time from 0 to 72 h (AUC 0 - t ) and the maximum concentration (C max ). The drugs were considered bioequivalent if the 90% confidence intervals (CI) of the T/R geometric mean ratios for C max and AUC 0 - t were in the range of 80-125%. Safety assessment included analysis of vital signs, physical examination, laboratory tests, 12-lead electrocardiography (ECG), and registration of adverse events (AEs) during the study. Results . Of the 46 randomized volunteers, 44 comprised the safety population. Forty two participants completed the study without significant protocol deviations and comprised the population for pharmacokinetic, statistical analysis and bioequivalence. The values of pharmacokinetic parameters T and R were comparable. The 90% CIs for C max and AUC 0 - t were within the acceptable bioequivalence range of 80,00-125,00% as follows: 91,71-107,41% and 91,58-115,83%, respectively. A total of 2 AEs were recorded in 1 participant after receiving the reference drug. The frequency of AEs did not differ between the groups. No clinically significant deviations in vital signs, physical examinations, laboratory tests, or ECG data were observed in either group during the study. Conclusion . T and R were considered bioequivalent and demonstrated similar safety profiles.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".