Evidence map›Paper›PMID 28748412›Full record

Trial reportClinical drug investigation2017

Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers.

Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan, Joga Gobburru

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03051685 (Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT03051685 phase1completednot on this map

Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults

TypeinterventionalSponsorDr. Reddy's Laboratories LimitedRan2015 to 2015Enrolled16ConditionsHealthyArmsDFN-15 Dose 1, DFN-15 Dose 2, DFN-15 Dose 3, Active Comparator
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. New Approaches to Shifting the Migraine Treatment Paradigm.Frontiers in pain research (Lausanne, Switzerland) · 2022
    Review
  10. Article
  11. Article
  12. Article
  13. 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 4 institutions in 3 countries.

Arindam PalProprietary Products, Dr. Reddy's Laboratories Ltd., Innovation Plaza, Survey Nos. 42, 44, 45 and 54, Quthubullapur, Bachupally, RR Dist, Hyderabad, Telangana, 500090, India. arindamp@drreddys.com.
Srinivas ShenoyProprietary Products, Dr. Reddy's Laboratories Ltd., Innovation Plaza, Survey Nos. 42, 44, 45 and 54, Quthubullapur, Bachupally, RR Dist, Hyderabad, Telangana, 500090, India.
Anirudh GautamProprietary Products, Dr. Reddy's Laboratories SA, Elisabethenanlage 11, 4051, Basel, Switzerland.
Sagar MunjalDr. Reddy's Laboratories, Inc., 107 College Road East, Princeton, NJ, 08540, USA.
Jing NiuCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
Mathangi GopalakrishnanCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
Joga GobburruCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
University of Maryland, Baltimore · USDr. Reddy's Laboratories (India) · INDr. Reddy's Laboratories (Switzerland) · CHDr. Reddy's Laboratories (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCOX-2 inhibitors can be effective for acute migraine, but none is supplied in a rapidly absorbed, ready-to-use oral liquid formulation. DFN-15, a novel oral liquid formulation of celecoxib, is being developed for the acute treatment of migraine with or without aura. Clinical studies with this formulation are ongoing.

objectivesThe objectives of the present study were to compare the bioavailability of DFN-15 with that of the commercial formulation of celecoxib 400-mg oral capsules (Celebrex

methodsThis single-dose randomized crossover study in 16 healthy fasted volunteers evaluated the pharmacokinetics and relative bioavailability of DFN-15 at doses of 120, 180, and 240 mg against the commercial formulation of celecoxib 400-mg oral capsules and determined the dose proportionality of DFN-15.

resultsThe maximum observed plasma concentrations (C

conclusionsBased on a faster rate of absorption and increased bioavailability, DFN-15 is being evaluated as an abortive medication for acute treatment in patients with migraine.

Indexed as

Administration, OralAdolescentAdultArea Under CurveBiological AvailabilityCapsulesCelecoxibCross-Over StudiesCyclooxygenase 2 InhibitorsFemaleHumansMaleMiddle AgedYoung AdultCapsulesCelecoxibCyclooxygenase 2 Inhibitors

Identifiers

PMID28748412
PMCPMC5602059
OpenAlexW2736745342

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.