An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of Single Entity Amphetamine Product) 30 mg, manufactured by Frontida Biopharm. Inc., Philadelphia, USA with Attent 30 mg (Mixed Amphetamine Salts tablets) manufactured by Teva Israel Ltd., in healthy adult, human subjects under fasting condition.
Phase 1
- Conditions
- ADHDMedDRA version: 23.0Level: LLTClassification code: 10064104Term: ADHD Class: 10037175Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-509874-48-00
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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 Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method