- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02607657
Pharmacokinetics of Eplerenone Tablet
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).
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.
Study Overview
Status
Conditions
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Eplerenone 25 mg
Eplerenone 25 mg Tablet Oral Once daily
|
|
EXPERIMENTAL: Eplerenone 50 mg
Eplerenone 50 mg Tablet Oral Once daily
|
|
EXPERIMENTAL: Eplerenone 100 mg
Eplerenone 100 mg (2 tablets of 50 mg) Tablet Oral Once daily
|
|
EXPERIMENTAL: Eplerenone 50 mg x 2
Eplerenone 50 mg Tablet Oral Twice daily
|
|
EXPERIMENTAL: Eplerenone 25 mg x 2
Eplerenone 25 mg Tablet Oral Twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Half-life (t1/2)
Time Frame: 24 hours
|
24 hours
|
Area under the curve(0-last)
Time Frame: 24 hours
|
24 hours
|
Area under the curve(0-all)
Time Frame: 24 hours
|
24 hours
|
Area under the curve(0-inf)
Time Frame: 24 hours
|
24 hours
|
Elimination rate constant (Ke)
Time Frame: 24 hours
|
24 hours
|
Maximum serum concentration (Cmax)
Time Frame: 24 hours
|
24 hours
|
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Time Frame: 24 hours
|
24 hours
|
Time of the last measurable (positive) concentration (tlast)
Time Frame: 24 hours
|
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
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events
Time Frame: 30 days
|
30 days
|
Intensity of adverse events
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GDN 055/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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