AN OPEN LABEL, TWO PERIODS, TWO SEQUENCES, CROSSOVER, RANDOMIZED MULTIPLE DOSE BIOEQUIVALENCE STUDY OF GUANFACINE 7 MG PROLONGED-RELEASE TABLETS (TEST FORMULATION) VS. EQUAL DOSE OF INTUNIV® PROLONGED-RELEASE TABLETS (REFERENCE FORMULATION) IN HEALTHY MALE VOLUNTEERS UNDER FASTING CONDITIONS
Phase 1
- Conditions
- Study performed on healthy volunteers.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-506596-10-00
- Lead Sponsor
- neuraxpharm Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method