Pharmacokinetics Study of Eplerenone Coated Tablets

NCT02957435 | Withdrawn Phase 1

• 1 other identifier: CAEP 56.005.16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics; Healthy Subjects; Fasting

Outcome Measures

Primary Outcomes (2)

• Maximum serum concentration (Cmax)

  24 hours

• Area under the curve (ASCo-t)

  24 hours

Secondary Outcomes (7)

• Time to reach Cmax (Tmax)

  24 hours

• Half-life (t1/2)

  24 hours

• Elimination constant rate (Kel)

  24 hours

• Area under the curve (0-inf)

  24 hours

• Number of adverse events

  30 days

Study Arms (1)

eplerenone

EXPERIMENTAL

(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3)

Drug: eplerenone

Interventions

eplerenone DRUG

(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3)

eplerenone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects, with age between 18 and 50 years old;
• Body mass index (BMI) between 18.5 and 30 kg/m2;
• Good health conditions or without significant diseases, at investigator discretion, according to the protocol and evaluation performed such as: clinical history, vital signs, physical examination, electrocardiogram (ECG) and laboratory exams;
• Ability to understand the nature and the objective of the trial, including risks and adverse effects.

You may not qualify if:

• Know hypersensitivity to the investigational product (eplerenone) or chemically related compounds;
• History or presence of chronic hepatic or gastrointestinal diseases, or other condition that may interfere with drug absorption, distribution, metabolism or excretion;
• Be in use of maintenance therapy with any drugs that interferes with the investigational product, except oral contraceptives;
• History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric diseases, hypertension of any etiology, history of myocardial infarction, angina and/or heart failure or malignant neoplasias, in other words, any current disease, acute or chronic, in monitoring or treatment;
• Electrocardiographic findings that at investigator discretion are not recommended for study participation;
• History of any cardiac surgery, kidney surgery (exeresis or kidney anegesis), intestinal (partial or full ablation of esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid or rectum) and liver or pancreas surgery;
• Laboratory exams results out of the range considered normal in accordance with the reference ranges stipulated by the clinical laboratory, unless that are considered as not clinically significant by the investigator);
• Be a smoker;
• Ingestion of food that contains xanthine including more than five cups of coffee or tea per day;
• Vegan habits;
• History of abusive use of drugs and/or alcohol or excessive alcohol consumption;
• Have used regular medication in two weeks prior to start of treatment and the date of evaluation or have used any medication one week before, except contraceptives or in cases that, based on the half-life of the drug and/or active metabolites may be assumed the complete elimination;
• Have been hospitalized for any reason up to 8 weeks prior to start of the first period of trial treatment;
• Have received any treatment with any drug with known and well-established toxic potential to major organs inside of the 3 months prior to the study;
• Have participated from any experimental trial or have ingested any investigational drug within 12 months prior to the trial start;

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

Study Sites (1)

CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, 13087567, Brazil

Location

MeSH Terms

Conditions

Fasting

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pedro S Junior, MD

  CAEP - Centro Avançado de Estudos e Pesquisa Ltda.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: July 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)