Trial reportClinical drug investigation2009
Effect of food on the pharmacokinetics of once-daily cyclobenzaprine extended-release 30 mg: a randomized, open-label, crossover, single-centre study.
Trial report in Clinical drug investigation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Pharmacokinetics of a Novel Anagrelide Extended-Release Formulation in Healthy Subjects: Food Intake and Comparison With a Reference Product.Clinical pharmacology in drug development · 2018Trial
- Pharmacokinetics and bioequivalence evaluation of cyclobenzaprine tablets.BioMed research international · 2013Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveFood can alter the bioavailability of the controlled-release formulations of many different drugs. This study assessed the effect of food on the pharmacokinetics of once-daily cyclobenzaprine extended-release (CER) in healthy adult subjects.
methodsHealthy adult volunteers were randomized in an open-label, two-period crossover design to receive a single dose of CER 30 mg on days 1 and 15 (separated by a 14-day drug washout) in either the fed or the fasted state. Pharmacokinetic measures included area under the plasma cyclobenzaprine concentration versus time curve to 168 hours (AUC(168)) and infinity (AUC(infinity)), maximum plasma cyclobenzaprine concentration (C(max)), time to observed C(max) (t(max)), terminal elimination half-life (t(1/2beta)), and absorption lag time (t(lag)). A food effect, as determined from the C(max) and the AUC, was established if the 90% confidence interval (CI) for the ratio of the mean fed/fasted values fell outside the range of 0.80 to 1.25. Adverse events were monitored throughout the study.
resultsSixteen healthy volunteers were enrolled (eight men, eight women; mean age 29.7 years), and 15 completed the study. No appreciable differences in the shape of the mean plasma cyclobenzaprine concentration versus time profile, t(lag) (2 hours) or t(max) (fed: 8 hours; fasted: 6 hours) were noted for CER 30 mg in the fed and fasted states. The least-squares mean ratio of fed to fasted state was 1.21 for AUC(168) (90% CI 1.11, 1.32), 1.20 for AUC(infinity) (90% CI 1.11, 1.31), and 1.36 for C(max) (90% CI 1.17, 1.57), which suggested a food effect. Most adverse events were mild in intensity and were comparable in the fed and fasted states.
conclusionThe results of this study show that an increase in systemic exposure is observed when CER 30 mg is taken with food. CER 30 mg was generally well tolerated, with comparable adverse events in both the fed and the fasted states. The increase in exposure did not appear to impact the tolerability of the formulation.
Indexed as
Identifiers
19243207What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.