Evidence map›Paper›PMID 18626633›Full record

Trial reportEuropean journal of clinical pharmacology2008

Oral absorption of propiverine solution and of the immediate and extended release dosage forms: influence of regioselective intestinal elimination.

Karen May, Thomas Giessmann, Danilo Wegner, Reinhard Oertel, Christiane Modess, Stefan Oswald, Manfred Braeter, Werner Siegmund

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. 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

8 authors at 3 institutions in 1 country.

Karen MayDepartment of Clinical Pharmacology, Ernst Moritz Arndt University, Friedrich-Loeffler-Str. 23d, 17487 Greifswald, Germany.
Thomas Giessmann
Danilo Wegner
Reinhard Oertel
Christiane Modess
Stefan Oswald
Manfred Braeter
Werner Siegmund
Universität Greifswald · DEApogepha Arzneimittel (Germany) · DETU Dresden · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe muscarine receptor antagonist propiverine in immediate release tablet form (IR) undergoes presystemic elimination mediated by CYP450 enzymes and intestinal efflux transporters. The aim of our study with propiverine IR and extended release (ER) was to determine whether propiverine disposition is dose linear, to compare the pharmacokinetics of propiverine in oral solution with IR and ER and to show how absorption rate is associated with bioavailability.

methodsThe pharmacokinetics of propiverine administered as intravenous propiverine (15 mg), 10, 15, and 30 mg propiverine IR, an oral propiverine solution (15 mg) and 10, 15, 30, and 45 mg propiverine ER were measured in two randomized, controlled, single-dose, five-period, cross-over studies, with each case involving a study cohort of ten healthy Caucasian subjects.

resultsDisposition of propiverine IR and ER was not dose-related. The bioavailability of ER was 64.5 +/- 16.1% compared to 50.3 +/- 13.4% (non-significant) after administration of the IR and propiverine solution (42.6 +/- 14.8%, p < 0.05). The mean absorption time (MAT) of ER (14.2 +/- 4.79 h) was significantly longer than that of the solution and IR (3.94 +/- 4.14 and 0.38 +/- 3.79 h, respectively; both p < 0.05). The bioavailability of propiverine was significantly correlated to the MAT (r = 0.521, p < 0.001). Renal excretion of the metabolite M-23 after propiverine ER administration (6.7 +/- 2.7%) was significantly lower than that after administration of the oral solution (10 +/- 2.2%) and of IR (9.8 +/- 2.7%; both p < 0.05).

conclusionsThe bioavailability of propiverine appears to be dependent on the intestinal site of dissolution and, consequently, on the extent of presystemic intestinal elimination.

Indexed as

AbsorptionAdministration, OralAdultArea Under CurveBenzilatesBiological AvailabilityCross-Over StudiesCytochrome P-450 CYP3ADelayed-Action PreparationsDose-Response Relationship, DrugFemaleHumansIntestinal MucosaMaleMuscarinic AntagonistsSolutionsBenzilatesCYP3A4 protein, humanCytochrome P-450 CYP3ADelayed-Action PreparationsMuscarinic AntagonistspropiverineSolutions

Identifiers

PMID18626633
OpenAlexW2013761368

What OpenQuestion holds

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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.