RBR-6cf4xh
Not yet recruiting
Phase 1
A Phase I/II clinical trial for evaluating safety and efficacy of an innovative medicine to nephrolithiasis treatment
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto0 sitesAugust 18, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nephrolithiasis
- Sponsor
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 55 years old; male; any race, healthy volunteers; non\-smoking; without drug addiction, use of alcohol or medicines.
Exclusion Criteria
- •Female; elderly (age\>55years); any clinically detectable disease, found on clinical history or physical examination; abnormal ECG (except unspecific ventricular repolarization changes, sinus brady/tachycardia); abnormal laboratory tests in blood cells count, kidney, reproductive, metabolic or hepatic function; participation in clinical trials in the last year; history of allergic reaction to medicines; use of any drug one week before the beginning or during the study.
Outcomes
Primary Outcomes
Not specified
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