Clinical trial • Phase II • Neurology
Lisdexamfetamine dimesylate for Attention deficit hyperactivity disorder
Phase II trial of Lisdexamfetamine dimesylate for Attention deficit hyperactivity disorder.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Attention deficit hyperactivity disorder
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 03-02-2025
Trial design
Randomised, lisdexamfetamine dimesylate 10 mg capsules (ohm laboratories inc.) vs vyvanse (lisdexamfetamine dimesylate) 10 mg capsules (takeda canada inc.); single-dose, two-period, two-sequence crossover, double-blinded, balanced, randomized bioequivalence design.-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Comparator
- Lisdexamfetamine Dimesylate 10 mg capsules (Ohm Laboratories Inc.) vs Vyvanse (Lisdexamfetamine Dimesylate) 10 mg capsules (Takeda Canada Inc.); single-dose, two-period, two-sequence crossover, double-blinded, balanced, randomized bioequivalence design.
- Crossover
- Yes
- Target Sample Size
- 64
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 64
Romania
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 03-02-2025
- Processing Time Days
- 52
- Number Of Sites
- 1
- Number Of Participants
- 64
Sites
- Site Name
- Terapia S.A.
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Lisdexamfetamine Dimesylate capsules 10 mg (Ohm Laboratories Inc.)
- Active Substance
- Lisdexamfetamine dimesylate
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsules)
- Route
- oral
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Frequency
- single dose
- Maximum Dose
- 10 mg
- Investigational Product Name
- Vyvanse (Lisdexamfetamine Dimesylate) 10 mg capsules (Takeda Canada Inc.)
- Active Substance
- Lisdexamfetamine dimesylate
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsules)
- Route
- oral
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Frequency
- single dose
- Maximum Dose
- 10 mg
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