Bioequivalence and Pharmacokinetic Evaluation of Ethambutol 400 Mg Film-Coated Tablet: A Single-Dose, Open-Label, Randomized, Two-Way Crossover Design Study
Bibliographic record
Abstract
The objective of this study was to determine the bioequivalence of Ethambutol 400 mg Film-Coated Tablet produced by PT Kimia Farma Tbk compared to the WHOrecommended comparator product, Myambutol 400 mg Film-Coated Tablet produced by Pantheon Inc, Ontario, Canada for STI Pharma LLC, in healthy subjects. The study design used was a randomised two-way crossover design, single dose, open label, under fasting conditions. The number of subjects who completed the study was 29 of 32. Blood samples were collected 18 times. Ethambutol concentrations were determined by LCMS/MS method. Bioequivalence was determined by value of 90% confidence interval (CI) with α = 5.00% within the range of 80.00–125.00% for AUC and Cmax. The results of the statistical analysis for the bioequivalence study comparing the test drug to the comparator drug showed a geometric mean ratio (90% CI) of 103.67% (97.23-110.52%) for the area under the concentration-time curve (AUC0-t) and 91.53% (84.80-98.79%) for the maximum concentration (Cmax). Based on the result, the test drug is bioequivalent to the comparator drug.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".