Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition.
This is a phase I study of eplerenone coated tablets of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in fasting administration. Sample size is 12 subjects, male and female, aged between 18 and 50 years old.
This is an open-label, unicenter study with three periods, three treatments and one sequence. Each subject will receive the following treatments at the following periods:
- Period 1: one coated tablet of eplerenone 25mg in fasting
- Period 2: one coated tablet of eplerenone 50mg in fasting
- Period 3: two coated tablets of eplerenone 50mg (100mg of eplerenone) in fasting Formulations will be administered in a single dose, orally in each period. Trial subjects will be admitted in three different periods of 24 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time for pharmacokinetics evaluation.
Primary objective is to evaluate the pharmacokinetics of formulations of eplerenone coated tablets of 25mg, 50mg and 100mg (two coated tablets of 50mg) in healthy subjects under fasting condition. As a secondary objective, it will be also evaluated the safe and tolerability of coated tablets of eplerenone.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
Not yet recruiting
Biolab Sanus Farmaceutica
Published on BioPortfolio: 2016-11-08T09:23:21-0500
This is a Phase I, open-label, randomized, parallel trial to evaluate the pharmacokinetics of Eplerenone tablet at different dosages (25 mg once daily, 50 mg once daily, 100 mg (2 tablets ...
The purpose of this study is to determine whether eplerenone is more effective than doubling the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of eq...
To evaluate the changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone daily for 10 days.
We investigated the eplerenone-induced, PI3K/Akt- and GSK-3β-mediated cardioprotection against ischemia/reperfusion (I/R) injury in diabetic rats. The study groups comprising diabetic rats were treat...
This study aimed to evaluate the role of eplerenone on the modulation of interleukin (IL)-1β and IL-33/sST2 signaling pathway in an experimental model of left ventricular (LV) systolic dysfunction af...
Nonalcoholic fatty liver disease is common in HIV, but there are no approved therapies. The aim of this open-label proof-of-concept study was to determine the effect of the mineralocorticoid receptor ...
Mineralocorticoid receptor (MR) antagonism may affect bone turnover via direct and indirect pathways involving parathyroid hormone, but randomized controlled trials are lacking. In a pre-specified ana...
Elagolix is a novel, orally active, non-peptide, competitive gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the management of endometriosis with associated pain and heavy...
Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.
Naturally occurring genetic variations associated with drug response (e.g., dosage, extent and rate of metabolic processes). While these variants are not markers for GENETIC PREDISPOSITION TO DISEASE they influence PHARMACOKINETICS and pharmacodynamics and often occur on genes encoding drug metabolism enzymes and transporters (e.g., ANGIOTENSIN CONVERTING ENZYME; CYTOCHROME P-450 CYP2D6).
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...