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 | Completed Phase 1

• 1 other identifier: C1B05273
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (2)

• Maximum measured plasma concentration (Cmax)

  90% confidence intervals for the geometric least squares mean ratio of (T/R) will be calculated and reported for Cmax

  72 hours

• Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)

  90% confidence intervals for the geometric least squares mean ratio of (T/R) will be calculated and reported for AUCt

  72 hours

Secondary Outcomes (2)

• The area under the plasma concentration versus time curve from zero to infinity (AUCi)

  72 hours

• Time of the maximum measured plasma concentration (Tmax)

  72 hours

Study Arms (2)

Lisdexamfetamine capsule

EXPERIMENTAL

Lisdexamfetamine 70 mg capsule

Drug: Lisdexamfetamine capsule; Drug: Elvanse® (Lisdexamfetamine dimesylate capsules, hard)

Elvanse® (Lisdexamfetamine dimesylate capsules, hard)

ACTIVE COMPARATOR

Elvanse® (Lisdexamfetamine dimesylate 70 mg capsules, hard)

Drug: Lisdexamfetamine capsule; Drug: Elvanse® (Lisdexamfetamine dimesylate capsules, hard)

Interventions

Lisdexamfetamine capsule DRUG

Lisdexamfetamine 70 mg capsule

Elvanse® (Lisdexamfetamine dimesylate capsules, hard); Lisdexamfetamine capsule

Elvanse® (Lisdexamfetamine dimesylate capsules, hard) DRUG

Elvanse® (Lisdexamfetamine dimesylate 70 mg capsules, hard)

Elvanse® (Lisdexamfetamine dimesylate capsules, hard); Lisdexamfetamine capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 55 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female.
• A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception. For female of child-bearing potential, acceptable forms of contraception included the following:
• i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• B. Female was not considered of child-bearing potential if one of the following was reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level \> 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value was rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
• Non-smokers and non-tobacco user (i.e. had no past history of smoking and tobacco consuming for at least one year prior to study).
• Able to communicate effectively with study personnel.
• Willing to provide written informed consent to participate in the study.
• All volunteers were assessed as normal and healthy by the principal investigator, co-investigator, or physician during the pre-study safety assessment conducted within 28 days of the first dose of study drug.

You may not qualify if:

• History of allergic responses to Lisdexamfetamine Dimesylate, sympathomimetic amines or other related drugs, or any of its formulation ingredients.
• Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, echocardiography, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
• History or presence of bronchial asthma.
• Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication.
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody.
• Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• Volunteers who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or \>200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
• Intolerance to venipuncture

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 380 051, India

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate; Hardness

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: May 26, 2025
• Primary Completion: June 6, 2025
• Study Completion: July 17, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IN (1)