Evidence map›Paper›PMID 30977301›Full record

Trial reportPharmacology research & perspectives2019

Levodopa-carbidopa intestinal gel high concentration formulation is clinically bioequivalent to commercial formulation.

Matthew Rosebraugh, Hari V Kalluri, Wei Liu, Charles Locke, Dilraj Sidhu, Jian-Hwa Han, Janet Benesh

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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.

Matthew RosebraughAbbVie Inc., North Chicago, llinois.ORCID 0000-0002-8333-7738
Hari V KalluriAbbVie Inc., North Chicago, llinois.
Wei LiuAbbVie Inc., North Chicago, llinois.
Charles LockeAbbVie Inc., North Chicago, llinois.
Dilraj SidhuAbbVie Inc., North Chicago, llinois.
Jian-Hwa HanAbbVie Inc., North Chicago, llinois.
Janet BeneshAbbVie Inc., North Chicago, llinois.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A new levodopa-carbidopa intestinal gel (LCIG) system featuring a higher levodopa/carbidopa (LD/CD) concentration and viscosity, LCIG-HV, is being developed to reduce the intrajejunal volume of LD/CD that is administered as compared to the current commercial formulation, LCIG-LV. This study characterizes the LCIG-HV formulation and compares it to the LCIG-LV formulation via dissolution testing and a clinical pharmacokinetic bioequivalence study. In vitro release profiles of LD/CD were determined using a USP Dissolution Apparatus 2 with 500 mL of phosphate buffer (pH 4.5) operating at 25 RPM. A single dose, open-label study was conducted according to a two-period, randomized, crossover design in 28 healthy subjects. The point estimate (PE) of the levodopa C

Indexed as

AdultAntiparkinson AgentsCarbidopaCross-Over StudiesDrug CombinationsDrug LiberationFemaleGelsHumansLevodopaMaleMiddle AgedTherapeutic EquivalencyAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsGelsLevodopabioequivalentcarbidopaintestinal gellevodopa

Identifiers

PMID30977301
PMCPMC6452870

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.