drugset / Trial / NCT02763800
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
RandomizedParallel-groupDouble-blindTreatment
Summary
The objectives as stated in the study protocol were as follows: * To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A * To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A * To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B * To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B
Timeline
- Start
- 2000-09
- Primary completion
- 2001-01
- Completion
- 2001-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nebicapone | Small molecule | 50 mg | Oral |
| Subject | Nebicapone | Small molecule | 100 mg | Oral |
| Subject | Nebicapone | Small molecule | 200 mg | Oral |