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Trial record 43 of 112 for:    EPLERENONE

Pharmacokinetics of Eplerenone Tablet

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ClinicalTrials.gov Identifier: NCT02607657
Recruitment Status : Withdrawn
First Posted : November 18, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • Area under the curve(0-last) [ Time Frame: 24 hours ]
  • Area under the curve(0-all) [ Time Frame: 24 hours ]
  • Area under the curve(0-inf) [ Time Frame: 24 hours ]
  • Half-life (t1/2) [ Time Frame: 24 hours ]
  • Elimination rate constant (Ke) [ Time Frame: 24 hours ]
  • Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
  • Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
  • Time of the last measurable (positive) concentration (tlast) [ Time Frame: 24 hours ]
  • Area under the first moment of the plasma concentration-time curve extrapolated from time zero to infinity as a percentage of total AUC [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Area under the curve(0-last) [ Time Frame: 24 hours ]
  • Area under the curve(0-all) [ Time Frame: 24 hours ]
  • Area under the curve(0-inf) [ Time Frame: 24 hours ]
  • Half-life (t1/2) [ Time Frame: 24 hours ]
  • Elimination rate constant (Ke) [ Time Frame: 24 hours ]
  • Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
  • Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
  • Time of the last measurable (positive) concentration (tlast) [ Time Frame: 24 hours ]
Change History Complete list of historical versions of study NCT02607657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Number of adverse events [ Time Frame: 30 days ]
  • Intensity of adverse events [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Eplerenone Tablet
Official Title  ICMJE Phase I Trial Comparing Eplerenone Pharmacokinetics (Tablet) in Different Dosages: 25mg, 50mg,100 mg Per Day and 100 mg (One 50 mg Tablet Every 12 Hours).
Brief Summary

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 of 50 mg) once daily and 50 mg twice daily). Sample size is 96 participants (24 per treatment group), male or female, aged between 18 and 50 years-old.

Primary objective is to evaluate pharmacokinetics of Eplerenone tablet at different dosages, and secondary objective is to evaluate safety and tolerability of the investigational product.

Study overall duration is approximately 12 weeks, including enrollment and follow-up visits. Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics.

Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Eplerenone 25 mg
  • Drug: Eplerenone 50 mg
  • Drug: Eplerenone 100 mg
  • Drug: Eplerenone 50 mg twice a day
  • Drug: Eplerenone 25 mg twice a day
Study Arms  ICMJE
  • Experimental: Eplerenone 25 mg
    Eplerenone 25 mg Tablet Oral Once daily
    Intervention: Drug: Eplerenone 25 mg
  • Experimental: Eplerenone 50 mg
    Eplerenone 50 mg Tablet Oral Once daily
    Intervention: Drug: Eplerenone 50 mg
  • Experimental: Eplerenone 100 mg
    Eplerenone 100 mg (2 tablets of 50 mg) Tablet Oral Once daily
    Intervention: Drug: Eplerenone 100 mg
  • Experimental: Eplerenone 50 mg x 2
    Eplerenone 50 mg Tablet Oral Twice daily
    Intervention: Drug: Eplerenone 50 mg twice a day
  • Experimental: Eplerenone 25 mg x 2
    Eplerenone 25 mg Tablet Oral Twice daily
    Intervention: Drug: Eplerenone 25 mg twice a day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
96
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female study participants, aged between 18 and 50 years-old;
  • Healthiness, according to clinical, laboratory and electrocardiographic evaluations;
  • Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

  • Known hypersensitivity to the investigational product (Eplerenone) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
  • History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism;
  • Chronic therapy with any drugs, except oral contraceptives;
  • History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure;
  • Electrocardiographic findings that, at investigator criteria, are not recommended for study participation;
  • Deviations on screening laboratory results that are considered clinically relevant by the researcher, preventing the subject to participate in the trial;
  • Smoking;
  • Intake of more that 5 cups of coffee or tea per day;
  • Unusual food habits, e.g., vegetarians;
  • History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day);
  • Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed;
  • Hospitalization for any reasons up to 8 weeks before trial;
  • Treatment, within 6 months before the trial, with any drugs with known and well-established toxic potential to major organs;
  • Participation in any other experimental research or administration of any experimental drug within 3 months before this trial;
  • Donation or loss of 450 mL or more of blood within 3 months before this trial or 3 donations (women)/4 donations (men) of blood within 12 months before this trial;
  • Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial;
  • Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607657
Other Study ID Numbers  ICMJE GDN 055/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biolab Sanus Farmaceutica
Study Sponsor  ICMJE Biolab Sanus Farmaceutica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.
PRS Account Biolab Sanus Farmaceutica
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP