Evidence map›Paper›PMID 37600497›Full record

Trial reportDrug design, development and therapy2023

Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial.

Ling Yang, Liangliang Zhang, Zhu Luo

Open access · goldAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact, top 76% 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

4 citing papers in PubMed, 0 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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

3 authors at 1 institution in 1 country.

Ling Yang *Department of Neurology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.ORCID 0000-0002-0594-4620
Liangliang Zhang *Department of Pulmonary and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Zhu LuoClinical Trial Center, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Sichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pramipexole dihydrochloride extended-release tablet is a novel long-acting form of non-ergot dopamine agonist indicated as one of main therapeutic approaches for Parkinson's disease. However, pharmacokinetic properties of extended-release pramipexole in healthy Chinese subjects remain unclear. Methods: A single-center, randomized, open-label, two-period crossover, single-dose study was performed to investigate comparative pharmacokinetics and evaluate bioequivalence of 0.375 mg test (Yangtze River Pharmaceutical Group Co., Ltd.) and reference (Trade name: Sifrol Results: A total of 56 subjects (28 in each dietary trial) were enrolled and randomized. After single dose of 0.375 mg test and reference formulations under fasted condition, main pharmacokinetics of pramipexole were as follows: peak concentration (C Conclusion: Test and reference formulations of pramipexole dihydrochloride extended-release tablets (0.375 mg) showed similar bioequivalence and well safety and tolerability in healthy Chinese subjects under fasted and fed states, which supports further investigations of test formulation in patients with Parkinson's disease.

Indexed as

Dopamine AgonistsEast Asian PeoplePramipexoleTherapeutic EquivalencyCross-Over StudiesDelayed-Action PreparationsEatingFastingHealthy VolunteersHumansParkinson DiseaseDelayed-Action PreparationsDopamine AgonistsPramipexolebioequivalenceParkinson’s diseasepharmacokineticspramipexole dihydrochloride extended-release tabletsafety

Identifiers

PMID37600497
PMCPMC10439801
OpenAlexW4385840647

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.