Evidence map›Paper›PMID 29022212›Full record

Trial reportClinical drug investigation2018

Effect of Food on the Pharmacokinetics of Saroglitazar Magnesium, a Novel Dual PPARαγ Agonist, in Healthy Adult Subjects.

Maulik R Patel, Kevinkumar A Kansagra, Devang P Parikh, Deven V Parmar, Hardik B Patel, Mayur M Soni, Uday S Patil, Harilal V Patel, Jaimik A Patel, Swagat S Gujarathi and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2018. 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
0.7field-weighted citation impact, top 31% 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, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  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

12 authors at 2 institutions in 1 country.

Maulik R PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India. maulikr.patel@zyduscadila.com.
Kevinkumar A KansagraZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Devang P ParikhZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Deven V ParmarZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Hardik B PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Mayur M SoniCliantha Research Limited, Ahmedabad, India.
Uday S PatilCliantha Research Limited, Ahmedabad, India.
Harilal V PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Jaimik A PatelCliantha Research Limited, Ahmedabad, India.
Swagat S GujarathiCliantha Research Limited, Ahmedabad, India.
Krupi V ParmarZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Nuggehally R SrinivasZydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Cadila Healthcare (India) · INCliantha (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivePeroxisome proliferator-activated receptors (PPARs) have recently become a focus of interest for their important roles in glucose and lipid metabolism. In humans, PPAR

methodsThis was a single-dose, open-label, randomized, single-treatment, two-period, two-conditions (fed vs. fasting), two-sequence, crossover study planned in 54 healthy subjects. Food effect (high-calorie and high-fat breakfast) was examined by comparing pharmacokinetic data of saroglitazar and its metabolite saroglitazar sulfoxide in plasma samples collected pre-dose and serially up to 72 h post-dose. Pharmacokinetic data were analyzed using the standard non-compartmental approach.

resultsA total of 54 subjects were enrolled in the study, out of them 50 subjects had completed the study and were analyzed. The presence of food had a minor impact on the disposition of saroglitazar. While food reduced C

conclusionFor the single-dose study, the absorption rate is affected by food as the 90% CI of C

Indexed as

Food-Drug InteractionsAdultArea Under CurveBiological AvailabilityCholesterol, HDLCross-Over StudiesEnergy IntakeFemaleHumansMalePhenylpropionatesPPAR alphaPyrrolesTabletsTherapeutic EquivalencyYoung AdultCholesterol, HDLPhenylpropionatesPPAR alphaPyrrolessaroglitazarTablets

Identifiers

PMID29022212
OpenAlexW2761299105

What OpenQuestion holds

Textmetadata
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.