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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.

NCT07098585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-01

No results posted yet for this study

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

DRUG

Lisdexamfetamine capsule

Lisdexamfetamine 70 mg capsule

DRUG

Elvanse® (Lisdexamfetamine dimesylate capsules, hard)

Elvanse® (Lisdexamfetamine dimesylate 70 mg capsules, hard)

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07098585 on ClinicalTrials.gov