Proton Pump Inhibitors Do Not Affect the Bioavailability of a Novel Liquid Formulation of Levothyroxine
Bibliographic record
Abstract
Objective This study evaluates the impact of a representative Proton Pump Inhibitor (PPI) (omeprazole), administered simultaneously or staggered, on the pharmacokinetics (PK) of levothyroxine (LT4) solution (Tirosint®-SOL). Methods This was a randomized, 3-way crossover, comparative bioavailability study in 36 healthy adults under fasting conditions. Omeprazole 40 mg delayed-release capsule was administered once daily from Day 1 to 6 (mornings, Treatment-A; evenings, Treatment-B; none, Treatment-C) to increase and stabilize gastric pH. In the morning of Day 5, a single dose of LT4 solution 600 mcg was administered. Blood samples were collected 0-48 hours post-LT4 administration. Noncompartmental PK parameters were calculated for total serum thyroxine (TT4) using baseline-corrected data. Maximum concentration (C max ) and area under the concentration-time curve (AUC 0-48 ) were included in an analysis of variance to obtain geometric mean ratios (GMR) and 90% confidence intervals (CIs). Results For both comparisons (A/C and B/C), GMR and 90% CIs for all parameters were within the equivalence boundaries (80%-125%), indicating bioequivalence: for A/C, AUC 0–48 98.98% [94-104%] and C max 91.68% [87-97%]; for B/C, AUC 0–48 98.94% [95-103%] and C max 94.90% [90-100%]. Median T max was similar across treatments. Conclusions This study demonstrated that Tirosint®-SOL bioavailability is unaffected by coadministration of a representative PPI, given simultaneously or staggered by about 12 hours, compared to administration of LT4 solution alone. For hypothyroid patients on PPI therapy, administration of LT4 solution may reduce variations in TSH levels related to intermittent use of acid-reducing drugs and consequently the need for dose adjustments.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".