Comparative Bioavailability Study of Two Antiretroviral FDC Containing Abacavir 600mg and Lamivudine 300mg in Healthy Human Indian Volunteers
Bibliographic record
Abstract
Introduction: Abacavir and Lamivudine both are nucleoside analogs acting as reverse transcriptase inhibitors (nRTI), widely used for the treatment of HIV infection. Both the drugs are in the World Health Organization's List of Essential Medicines, which contains the most important medications needed for a basic health system. Materials and Methods: In this present investigation, a randomized, two period, two treatment cross over study of test preparation of FDC tablet containing abacavir 600mg and lamivudine 300mg of Lok-Beta Pharmaceuticals Pvt. Ltd. Mumbai and reference preparation Abamune-L 600/300mg Tablet (containing abacavir 600mg and lamivudine 300mg) of Cipla Laboratories Ltd, India have been carried out in 24+2 healthy male, adult, human volunteers under fasting condition to establish the bioequivalence of the test formulation with comparison to the reference formulation. The clinical study of two tablet formulations, one as reference and other one as test FDC tablet containing abacavir 600mg and lamivudine 300mg was performed in 24 healthy male Indian volunteers. This was a single dose, two periods and randomized crossover study with a washout period of one week. The formulations were compared using the parameters such as Area under the plasma concentration-time curve (AUC 0 -t), Area under the plasma concentration-time curve from zero to infinity (AUC 0-∞ ), Peak plasma concentration (C max ), and time to reach peak plasma concentration (t max ). Results: Plasma samples for pharmacokinetic analysis were collected before dosing as well as at the pre-specified time points after dosing. The concentrations of the analytes in plasma were determined by a validated LC-MS/MS method using nevirapine as an internal standard. The 90% confidence intervals of the mean values for the test/reference ratios for AUC and C max to compare these results with the bioequivalence acceptance are ranged 0.80-1.25 .The relative bioavailability of the test preparation were found to be 104.00% and 101.65% for abacavir and lamivudine respectively Conclusion: On the basis of comparison of the AUC 0-t and the relative bioavailability of the test and reference preparation this can be concluded that the test preparation is found to be bioequivalent with the reference preparation.
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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 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| 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".