The Pharmacokinetics of Pantoprazole Delayed Release Granules Administered by Three Different Methods in Healthy Subjects
Bibliographic record
Abstract
Purpose: A new oral delayed release granule formulation of pantoprazole was developed as an alternative for adult subjects who cannot swallow tablets. The primary objective of this study was to determine the bioequivalence of this new formulation administered by 3 different methods in healthy subjects. Methods: This was a randomized, open-label, 3-period, crossover, in-patient study in 25 healthy adult subjects aged 18 to 50 years. Each subject received a single 40 mg dose of pantoprazole after at least a 10 hour fast for each of the following administration methods separated by a washout period: 1) granules sprinkled over applesauce; 2) granules mixed with apple juice; 3) granules mixed with apple juice and administered through a nasogastric (NG) tube. Blood samples were collected up to 24 hours post dose and analyzed for pantoprazole levels by a validated LC/MS/MS method. Standard safety evaluations were performed. The PK parameters were estimated using non-compartmental methods. The 90% confidence limits for the test-to-reference geometric mean ratio were calculated for Cmax and AUC. Results: The mean Cmax, AUCT, and AUC values were similar for the 3 dosing methods. For Cmax, AUCT, and AUC, the 90% CI's for the ratio of the geometric means were within the bioequivalent limits of 80%–125%. Four subjects reported adverse events while on treatment including: headache, diarrhea, bronchitis, increased cough, epistaxis, and local reaction to the NG tube. There were no deaths, serious adverse events, or discontinuations. Conclusions: Pantoprazole granules administered with apple juice orally or through an NG tube, or with applesauce are bioequivalent. Pantoprazole granules were safe and well tolerated when administered by the above methods.
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 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".