Bioequivalence study of a film-coated tablet of deferiprone in healthy Thai volunteers
Bibliographic record
Abstract
OBJECTIVE: To evaluate the bioequivalence of a single dose of deferiprone tablet manufactured locally (GPO-L-ONE, GPO, Thailand) with a reference formulation (Ferriprox, ApoPharma, Canada). VOLUNTEERS AND METHODS: A randomized, single dose, two-treatment, two-period, two- sequence crossover study was conducted in 24 healthy volunteers. Each subject received a single dose of 3 tablets of 500 mg deferiprone of both formulations with a two-week washout period. Blood samples were collected at 12 points for 480 min. Serum deferiprone levels were analyzed using high performance liquid chromatography (HPLC) method. Pharmacokinetic parameters were calculated from serum concentration-time curve and applying the non-compartment model. Statistical comparisons of Cmax, AUC(0-t), AUC(0-inf) values were evaluated after logarithmic transformation. Other pharmacokinetic parameters were tested non-parametrically. RESULTS: The C(max) value (mean +/- SD) for reference and test product was 32.4 +/- 13.2 and 27.8 +/- 12.8 microg/ml, respectively. Mean ratio (test/reference) of C(max) was 0.852 with 90% CI of 0.772 - 0.934. Mean ratio (test/reference) of AUC(0-t) was 0.962 with 90% CI of 0.914 to 1.012, and of AUC(0-inf) was 0.966 with 90% CI of 0.918-1.016. Both formulations were well tolerated and no adverse effects were observed. CONCLUSION: The 90% CI of mean ratio of AUC(0-t) and AUC(0-inf) fell within the acceptable range (0.80 - 1.25) for bioequivalent eligibility. Regarding the efficacy of deferiprone, which depends on AUC rather than C(max), 90% CI of mean ratio of C(max) was within the acceptable range of WHO criteria for bioequivalence study (0.75 - 1.33). Therefore the two film-coated formulations of deferiprone tablet were proven bioequivalent in healthy Thai volunteers.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".