NCT07098585

To Compare and Evaluate the Oral Bioavailability of Lisdexamfetamine 70 mg Capsule With That of Elvanse® 70 mg Capsules, Hard Lisdexamfetamine Dimesylate in Healthy, Adult, Human Subjects Under Fasting Conditions.

An Open Label, Randomized, Two-period, Two-treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study in Healthy Adult Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study in healthy adult human subjects under fasting conditions.

Conditions

• Attention Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine capsule	Lisdexamfetamine 70 mg capsule
DRUG	Elvanse® (Lisdexamfetamine dimesylate capsules, hard)	Elvanse® (Lisdexamfetamine dimesylate 70 mg capsules, hard)

Timeline

• Start date: 2025-05-26
• Primary completion: 2025-06-06
• Completion: 2025-07-17
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: India