Scientific Publications
Research articles constitute the means that validates our scientific activities through their publication in different national and/or international refereed journals. Press activities allow us to communicate our experience in research projects and, together with advertising in different graphic media, our trajectory.
Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in helthy adults
July 28, 2023
A Gamma Variant RDB-based aluminium hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18 - 55 years old) with a complete COVID-19 primary vacine scheme were assigned to receive two intramuscular doses of either a lowdose or high-dose of ARVAC CG.
Pharmacokinetics of a new fixed-dose combination of candesartan cilexetil, hydrochlorothiazide, and rosuvastatin in healthy adult subjects
May 18, 2021
Cardiovascular disease is the primary cause of death globally based on data from the World Health Organization, with an estimated 18 million deaths each year, constituting 31% of all deaths [1]. Moreover, in spite of current recommendations and availability of effective medication, more than 23 million people are predicted to die annually from cardiovascular diseases by 2030 [2]. Dyslipidemia and hypertension are well recognized risk factors for heart disease and stroke [3].
Clinical investigation of the biopharmaceutical characteristics of nifurtimox tablets – Implications for quality control and application
July 12, 2021
Nifurtimox is approved in Chagas disease and has been used in endemic countries since the 1960s. Nifurtimox, available as a 120 mg tablet, is administered with food typically three times daily, and dosage is adjusted for age and bodyweight. Accurately or reproducibly fragmenting the 120 mg tablet for dose adjustment in young children and those with low body weight is problematic.
Audit Record FV-RE-10 VD01 FP Clinical Pharma (Argentina)
April 27, 2021
During the audit, the process of collecting, evaluating, interpreting, coding and reporting adverse reactions was reviewed in detail, which is the activity for which Spedrog Caillon has subcontracted the services of FP Clinical Pharma. This process had been previously described in the audit questionnaire that had been received on 03/31/2021.
Biopharmaceutical Characteristics of Nifurtimox Tablets for Age and Body Weight-Adjusted Dosing in Patients With Chagas Disease
September 2, 2020
Treatment of Chagas disease with nifurtimox requires age- and body weight-adjusted dosing, resulting in complex dosing instructions. Appropriate formulations are needed for precise and compliant dosing, especially in pediatric patients. We characterized the biopharmaceutical features of a standard nifurtimox 120-mg tablet and a 30-mg tablet developed to improve dose accuracy. Two open-label, randomized crossover studies were conducted in adult outpatients with Chagas disease.
Comparative Bioavailability of a New Fixed Dose Combination Tablet Containing Lumacaftor/ Ivacaftor in Healthy Subjects: A Randomized, Single-Dose, 2-Way Crossover Study
September 13, 2019
Lumacaftor (LUM) has been clinically developed in combination with ivacaftor (IVA) as a fixed-dose combination (FDC) tablet for oral administration for the treatment of Cystic fibrosis (CF), a chronically autosomal recessive genetic disease affecting more than 70,000 people worldwide with a median age of death of approximately 30.6 years in the United States [1,2]. CF is caused by a mutation in the gene that encodes for the CF transmembrane conductance regulator (CFTR) protein [3]. The CFTR protein is an epithelial chloride channel located in multiple organs, being responsible for maintaining the regulation of salt and water absorption and secretion [4].
Comparative Bioavailability of Two Oral Perampanel Formulations in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study
September 5, 2017
Perampanel (CAS 380917-97-5) is an Antiepileptic Drug (AED) with novel mechanism of action due to its selective, non-competitive AMPA glutamate receptor antagonist [1]. A subtype glutamate receptor, AMPA (a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) has been an active target for epilepsy drug development because it seems to participate in the induction and spread of epileptic seizures [2]. Phase III clinical trials have established the efficacy and safety of perampanel as adjunctive therapy for partial seizures with or without secondary generalized seizures in patients with epilepsy aged =12 years old [3 - 5]. Perampanel oral film-coated tablet formulations were developed to enhance patient adherence to treatment. A hallmark of perampanel is its long half-life allowing just a one daily dose which contribute to the patient drug compliance [6].
Effect of a high-calorie, high-fat meal on the pharmacokinetics of oral nifurtimox in adults with chronic Chagas’ disease
2016
Nifurtimox (NFX) is one of only two treatments for patients with Chagas’ Disease (CD); a 30 mg tablet suitable for age-appropriate dosing of pediatric CD patients has been developed recently. As NFX is a poorly soluble and highly permeable drug, food can have a considerable effect on its uptake from the GI tract. We therefore conducted a Phase I study to investigate this possible food effect, initially in adults.
Plasma Enalapril Kinetics of Two Modified Formulations Tested in Healthy Volunteers. A Pilot Trial Searching for an Optimum Blood Pressure Control.
July 2016
However, few data exist on central systolic and diastolic pressures (SBPC, DBPC) and arterial stiffness in these patients, and the effect of treatment on them.In this study we present the findings of a group of patients (P) receiving treatment established by their general pressure and pulse wave velocity (PWV) between men and women with IH with treatment prescribed by their general practitioner.
Pharmacokinetic Drug-drug Interaction Study of Benznidazole and E1224 in Healthy Male Volunteers
September 2015
Chagas disease (CD) is an important global neglected tropical disease, where new, better tolerated, therapeutic options are needed. Benznidazole (BNZ) is the drug of choice for treating adults and children with CD. E1224 (ravuconazole ([RVZ]) prodrug) is an antifungal drug with promising anti-T. cruzi activity, but unsatisfactory clinical results in monotherapy. Combination treatment is a well-recognised treatment modality, with potential in CD to improve efficacy and safety and reduce putative risk of resistance. Little is known about the metabolism and absorption of BNZ, therefore its interaction with other drugs cannot be easily anticipated. An in vivo interaction study in healthy volunteers was designed to assess the pharmacokinetics (PK) and safety interaction of BNZ and E1224.
Single-Dose Bioequivalence of a New Fixed-Dose Combination Tablet Containing Tenofovir Disoproxil Fumarate and Lamivudine
2011
Tenofovir disoproxil himarate (TDF) is a nucleotide analog reverse transcriptase inhibitor orally bioavailable as an ester-derived prodnig which requires &ester hydrolysis for conversion to tenofovir (TFV) and subsequent intracellular phosphorylations by cellular enzymes to the active metabolite, tenofovir diphosphate, which is a competitive inhibitor of HIV-1 reverse transcriptase, leading to the prevention of DNA chain elongation and termination of viral DNA growth [1,2].
Bloequivalence study of two oral tablet formulations containing saquinavir mesylate boosted with ritonavir in healthy male subjects
2011
Saquinavir (SAQ) is a potent inhibitor of the 1-11V-1 pro-tease and It is a well established component of current highly active antiretrovirel therapy (HAART) regimen's [1-6]. SAQ is a peptide-like substrate analogue that binds to the HIV protease active site and inhibits its ac-tivity which prevents cleavage of the viral polyproteins resulting in the formation of immature noninfectious virus particles, SAQ mesylate (CAS 149845-06-7) 500 mg film coated tablet (FCT) formulation was firstly devel-oped to support patient adherence to treatment by re-ducing daily pill burden and was approved by the Food and Drug Administration (FDA), USA in 2005 after de-monstrating bioequivalence to SAQ 200 mg hard cap-sules [1].
Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers
2011
Tenofovir disoproxil fumarate (TDF, CAS 147127-20.6) is an orally bioavailable ester-derived prodrug which is converted in vivo by serum and tissue esterases to teno-fovir (TFV), an acyclic nucleotide. Intracellular phos-phorylation of TFV yields the active metabolite, tenofo-vir diphosphate, which is a competitive inhibitor of 141V-1 reverse transcriptase, leading to the prevention of DNA chain elongation and termination of viral DNA growth 11-31. TFV was approved by the Food and Drug Administration (FDA) in October 2001 and is indicated for use in combination with other antiretroviral agents for the management of HIV-1 infection [4 - 6].
Healthy volunteers for bioequivalence trials: predictive factors for enrollment failures - a case - control study
March 2011
A determinant factor for the success of a clinical trial is the adequate selection of the study population which allows the recruit-ment and enrollment of subjects who fulfill protocol criteria [1]. A subject is considered to be recruited when he/she signs the in-formed Consent Form document; then a sub-ject is considered enrolled if he/she fulfills the eligibility criteria and is effectively included in the study.
Basic Principles in Pharmaceutical Research
2003
The discovery of a new molecule begins in the context of basic science in the laboratory setting, where the synthesis of a new drug occurs along with the development of a biological response in vitro that anticipates a potential therapeutic effect. An extensive battery of so-called pre-clinical tests - In Vitro tests on tissues, animal models, physical-chemical and manufacturing tests - precede the first administration of this new molecule in a small number of human beings (tests of Phase I). The purpose of preclinical trials is to obtain data that supports, with a certain degree of security, the decision to use the drug in humans.
Single Dose Bioequivalence Study of Mycophenolate Mofetil 500 in Healthy Volunteer Subjects
October 29, 2009
Mycophenolate mofetil (MMF) is a prodrug of mycophenolic acid (MPA), used in immunosuppressive therapy to inhibit the rejection of solid organ transplants. MPA has low and erratic oral absorption. Its prodrug, MMF (2-morpholino-ethyl-ester), was developed to increase its bioavailability, because it is well absorbed from the gastrointestinal tract and rapidly hydrolyzed to become the active ingredient, MPA. Sandoz Laboratories S.A. developed a solid oral formulation containing 500 mg of mycophenolate mofetil (test product) pharmaceutical equivalent to Cellcept® from Roche Products (reference product). The evaluation of Bioequivalence of immunosuppressive medications is a regulatory requirement in Argentina because these are drugs with high variability in serum concentrations and require therapeutic monitoring.
Relative Bioavailability of Two Drug Products of Somatropin Obtained from Either the Milk of Transgenic Cows or Bacterial Culture
March 9, 2010
Growth hormone (GE) therapy with exogenous human growth hormone (hGH) has been used for many decades to treat children with GH deficiency (GHD) [I, 21. to the early times, the supply could not meet the demand to all patients with GHD. Since 1985, hGH produced uswg recombinant DNA technology has been approved and has been assigned the international non-proprietary name somatropin, with the Anatomical Therapeutic Chemical M.E.C. and R,A.D. are staff of Bra Sidurx S.A.; J, F. and I.B. are paid advi-sors to Bic Sidius 5.A.; FP Clinical and CDM were contracted for the execution of this study.
Journal Pre-proof
Buenos Aires, October 27, 2009
Clinical investigation of the biopharmaceutical characteristics of nifurtimox tablets – implications for quality control and application Heino Stass, Sarah Just, Boris Weimann, Ibrahim Ince, Stefan Willmann, Ethel Feleder, Cecilia Freitas, Gustavo Yerino, Uwe M¨unster. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Bioequivalence Study in Healthy Volunteers of Zidovudine, Abacavir and Lamivudine in a Single Dose of Two Different Formulations: Trivudin® and Tricivir®
Buenos Aires, October 27, 2009
Combination therapy with antiretroviral drugs for the treatment of HIV in adults is currently the first-line treatment. The combination of three nucleoside reverse transcription inhibitors (NRTIs) is recommended as one of the first lines of treatment. In this sense, the development of oral formulations containing a triple combination at a fixed dose is essential to promote patient adherence to treatment. Richmond Laboratories has developed a solid oral formulation Trivudin® that contains a fixed-dose combination of three NRTIs: Abacavir 300 mg, Lamivudine 150 mg and Zidovudine 300 mg pharmaceutical equivalent to the product Tricivir® from GlaxoSmithKline S.A.
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