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).

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-10-01
• First posted: 2015-11-18
• Last updated: 2017-02-01