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Pharmacokinetics of Eplerenone Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02607657
Recruitment Status : Withdrawn
First Posted : November 18, 2015
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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).
Study Start Date : May 2016
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone 25 mg
Eplerenone 25 mg Tablet Oral Once daily
Drug: Eplerenone 25 mg
Experimental: Eplerenone 50 mg
Eplerenone 50 mg Tablet Oral Once daily
Drug: Eplerenone 50 mg
Experimental: Eplerenone 100 mg
Eplerenone 100 mg (2 tablets of 50 mg) Tablet Oral Once daily
Drug: Eplerenone 100 mg
Experimental: Eplerenone 50 mg x 2
Eplerenone 50 mg Tablet Oral Twice daily
Drug: Eplerenone 50 mg twice a day
Experimental: Eplerenone 25 mg x 2
Eplerenone 25 mg Tablet Oral Twice daily
Drug: Eplerenone 25 mg twice a day

Primary Outcome Measures :
  1. Area under the curve(0-last) [ Time Frame: 24 hours ]
  2. Area under the curve(0-all) [ Time Frame: 24 hours ]
  3. Area under the curve(0-inf) [ Time Frame: 24 hours ]
  4. Half-life (t1/2) [ Time Frame: 24 hours ]
  5. Elimination rate constant (Ke) [ Time Frame: 24 hours ]
  6. Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
  7. Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
  8. Time of the last measurable (positive) concentration (tlast) [ Time Frame: 24 hours ]
  9. 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 ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 30 days ]
  2. Intensity of adverse events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02607657

Sponsors and Collaborators
Biolab Sanus Farmaceutica
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Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.
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Responsible Party: Biolab Sanus Farmaceutica Identifier: NCT02607657    
Other Study ID Numbers: GDN 055/15
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents