Healthy Volunteers Clinical Trial
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).
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.
n/a
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