Bioequivalence Study of Lisdexamfetamine Dimesilate 50 & 70 mg Capsule of Test Drug (Faran Shimi, Iran)

Bioequivalence Study of Lisdexamfetamine Dimesilate 50 & 70 mg Capsule of Test (ATTVANSE®, Faran Shimi, Iran) and Reference Drug (VYVANSE® 50 & 70 mg Capsule, Takeda, Canada)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N153

Enrollment

Registered

2025-09-18

Start date

2025-09-15

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers.

Interventions

Intervention 1: Intervention group: Lisdexamfetamine Dimesilate 50 & 70 mg Capsule of the Test Drug (Faran Shimi, Iran) is admintered in the first period. Cross-over design with 2 weeks washout period

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy subjects No underlying metabolic or cardiovascular disease 18-55 years old

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Smoking or drug abuse Allergic to drug or any components of formulation

Design outcomes

Primary

Measure	Time frame
Drug concentration in blood. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 6, 8, 10 hours after drug administration. Method of measurement: Liquid Chromatography with Mass/Mass Detector.	—

Secondary

Measure	Time frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the instrumental analysis of the samples using the WinNonLin software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time plots.	—

Measure

Time frame

Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the instrumental analysis of the samples using the WinNonLin software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time plots.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026