Bioequivalence of Tramadol hydrochloride orally disintegrating tablet in healthy volunteers
Bibliographic record
Abstract
OBJECTIVE To evaluate the bioequivalence of Tramadol hydrochloride(TH) orally distintegrating tablets(test preparations) and TH tablets(reference preparations) in Chinese healthy volunteers.METHODSSerum samples were extracted by liquid-liquid extraction methods,and blood drug concentrations of TH were measured by HPLC.Eighteen healthy male volunteers were divided randomly into 2 groups.According to two-formulas double-period crossover protocol,volunteers in each group were administrated with an single oral dose of TH(100 mg) in two weeks.The pharmacokinetic parameters of two preparations were calculated and the bioequivalence were evaluated.RESULTSThe main pharmacokinetic parameters of the test preparations and the reference preparations were as follows: t1/2 7.6±2.2 and 7.3±1.8 h,Tmax1.9±0.8 and 1.8±0.8 h,Cmax 282.2±58.6 and 285.0±55.7 μg·L-1,AUC0-t 2.454±0.647 and 2.574±0.715 mg·h·L-1,AUC0-∞ 2.756±0.722 and 2.851±0.737 mg·h·L-1.CONCLUSIONThe two preparations are bioequivalent.Compared with reference preparations,the bioavailability of tested preparations is 96.3%±8.2%.
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 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) | 0.000 | 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 | 0.000 | 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".