Healthy Subjects Clinical Trial
Official title:
Phase I, Open-label, Three Periods Study in Health Male and Female Subjects, Under Fasting Condition for Evaluation of Pharmacokinetics Profile of Single Dose of Eplerenone in Coated Tablets Formulation on Concentrations of 25mg, 50mg and 100mg, Produced by Biolab Sanus Farmacêutica Ltda
The purpose of this study is to evaluate the pharmacokinetics profile of the formulation of eplerenone coated tablets in the concentration of 25mg, 50mg and 100mg (2 coated tablets of 50mg) in male and female healthy subjects under fasting condition.
This is a phase I study of eplerenone coated tablets of 25mg, 50mg and 100mg (2 coated
tablets of 50mg) in fasting administration. Sample size is 12 subjects, male and female, aged
between 18 and 50 years old.
This is an open-label, unicenter study with three periods, three treatments and one sequence.
Each subject will receive the following treatments at the following periods:
- Period 1: one coated tablet of eplerenone 25mg in fasting
- Period 2: one coated tablet of eplerenone 50mg in fasting
- Period 3: two coated tablets of eplerenone 50mg (100mg of eplerenone) in fasting
Formulations will be administered in a single dose, orally in each period. Trial
subjects will be admitted in three different periods of 24 hours each, when
investigational product will be administered and blood samples will be collected at
pre-determined periods of time for pharmacokinetics evaluation.
Primary objective is to evaluate the pharmacokinetics of formulations of eplerenone coated
tablets of 25mg, 50mg and 100mg (two coated tablets of 50mg) in healthy subjects under
fasting condition. As a secondary objective, it will be also evaluated the safe and
tolerability of coated tablets of eplerenone.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
| Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
| Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
| Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06248801 -
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
|
Phase 1 | |
| Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
| Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
| Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
| Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
| Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
| Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
| Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
| Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
| Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
| Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 |