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.

Phase 1 Completed 48 enrolled Humanis

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2025-05-26
Primary completion: 2025-06-06
Completion: 2025-07-17

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elvanse®	Unknown	70 mg	Oral
Subject	Lisdexamfetamine	Other / unclassified	70 mg	Oral

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.

Summary

Timeline

Drugs

Indications