Evidence map›Paper›PMID 24151591›Full record

Trial reportBioMed research international2013

Pharmacokinetics and bioequivalence evaluation of cyclobenzaprine tablets.

Tatiane Maria de Lima Souza Brioschi, Simone Grigoleto Schramm, Eunice Kazue Kano, Eunice Emiko Mori Koono, Ting Hui Ching, Cristina Helena Dos Reis Serra, Valentina Porta

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BioMed research international, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
5.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 24 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Tatiane Maria de Lima Souza BrioschiFaculty of Pharmaceutical Sciences, University of São Paulo, 580 Avenida Prof. Lineu Prestes, 05508900 São Paulo, SP, Brazil.
Simone Grigoleto Schramm
Eunice Kazue Kano
Eunice Emiko Mori Koono
Ting Hui Ching
Cristina Helena Dos Reis Serra
Valentina Porta
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different tablet formulations containing the drug. An open, randomized, crossover, single-dose, two-period, and two-sequence design was employed. Tablets were administered to 23 healthy subjects after an overnight fasting and blood samples were collected up to 240 hours after drug administration. Plasma cyclobenzaprine was quantified by means of an LC-MS/MS method. Pharmacokinetic parameters related to absorption, distribution, and elimination were calculated. Cyclobenzaprine plasma profiles for the reference and test products were similar, as well as absorption pharmacokinetic parameters AUC (reference: 199.4 ng ∗ h/mL; test: 201.6 ng ∗ h/mL), Cmax (reference: 7.0 ng/mL; test: 7.2 ng/mL), and T(max) (reference: 4.5 h; test: 4.6 h). Bioequivalence was evaluated by means of 90% confidence intervals for the ratio of AUC (93%-111%) and C(max) (93%-112%) values for test and reference products, which were within the 80%-125% interval proposed by FDA. Cyclobenzaprine pharmacokinetics can be described by a multicompartment open model with an average rapid elimination half-life (t(1/2)β) of 3.1 hours and an average terminal elimination half-life (t(1/2)γ) of 31.9 hours.

Indexed as

Therapeutic EquivalencyAmitriptylineAntidepressive AgentsChromatography, High Pressure LiquidDepressionHalf-LifeHealthy VolunteersHumansTabletsTandem Mass SpectrometryUnited StatesAmitriptylineAntidepressive AgentscyclobenzaprineTablets

Identifiers

PMID24151591
PMCPMC3787571
OpenAlexW2001413169

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.