Evidence map›Paper›PMID 27923408›Full record

ArticleBMC pharmacology & toxicology2016

Pharmacokinetic and pharmacodynamic characterization of a novel formulation containing co-formulated interferons alpha-2b and gamma in healthy male volunteers.

Idrian García-García, Ignacio Hernández-González, Alina Díaz-Machado, Carlos A González-Delgado, Sonia Pérez-Rodríguez, Yanelda García-Vega, Rosario Campos-Mojena, Ángela D Tuero-Iglesias, Carmen M Valenzuela-Silva, Alieski Cruz-Ramírez and 5 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC pharmacology & toxicology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
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

15 authors at 3 institutions in 1 country.

Idrian García-GarcíaClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Ignacio Hernández-GonzálezIsotope Center, San José de las Lajas, Mayabeque, Cuba.
Alina Díaz-MachadoNational Center for Toxicology, "Carlos J. Finlay" University Hospital, Havana, Cuba.
Carlos A González-DelgadoNational Center for Toxicology, "Carlos J. Finlay" University Hospital, Havana, Cuba.
Sonia Pérez-RodríguezNational Center for Toxicology, "Carlos J. Finlay" University Hospital, Havana, Cuba.
Yanelda García-VegaClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Rosario Campos-MojenaClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Ángela D Tuero-IglesiasClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Carmen M Valenzuela-SilvaClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Alieski Cruz-RamírezClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Alis Martín-TrujilloNational Center for Toxicology, "Carlos J. Finlay" University Hospital, Havana, Cuba.
Héctor Santana-MiliánDevelopment Direction, Center for Genetic Engineering and Biotechnology, Havana, Cuba.
Pedro A López-SauraClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba.
Iraldo Bello-RiveroClinical Research Direction, Center for Genetic Engineering and Biotechnology, Ave. 134 b/23 and 25, Cubanacán, Playa, P.O. Box 6332, Havana, Cuba. iraldo.bello@cigb.edu.cu.
CIGB-128-A Study Group
Centro de Ingeniería Genética y Biotecnología · CUFinlay Institute · CUCentro Nacional de Sanidad Agropecuaria · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore potent antitumor activity is desired in Interferon (IFN)-treated cancer patients. This could be achieved by combining IFN alpha and IFN gamma. The aim of this work was to characterize the pharmacokinetics and pharmacodynamics of a novel formulation containing a co-formulated combination of IFNs alpha-2b and gamma (CIGB-128-A).

methodsA group of nine healthy male subjects received intramuscularly 24.5 × 10

resultsConcerning pharmacokinetics, serum IFNs' profiles were better fitted to a mono-compartmental model with consecutive zero order and first order absorption, one bioavailability value. No interferences by simultaneous administered IFNs were observed in their typical similar systemic profiles. Neopterin and β

conclusionsThe administration of co-formulated IFN alpha-2b and IFN gamma likely provides improved pharmacodynamic properties that may be beneficial to treat several malignancies.

trial registrationCuban Public Registry of Clinical Trials RPCEC00000118 , May 24, 2011.

Indexed as

AdultDrug CombinationsDrug CompoundingHealthy VolunteersHumansInjections, IntramuscularInterferon-alphaInterferon alpha-2Interferon-gammaMaleRecombinant ProteinsYoung AdultDrug CombinationsInterferon-alphaInterferon alpha-2Interferon-gammaRecombinant Proteins2′–5′ oligoadenylate synthetaseBeta2-microglobulinInterferonsNeopterinPharmacodynamicsPharmacokinetics

Identifiers

PMID27923408
PMCPMC5142133
OpenAlexW2553266524

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.