Bioequivalence study of Amantadine 100 mg capsule

In vivo bioequivalence study of Amantadine 100 mg capsule manufactured by Aani Darman Co. compared with innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N82

Enrollment

Registered

2025-07-26

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Amantadine 100 mg capsule manufactured by Aani darman) in fasted state. Blood samples will be

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age (18-55 years)

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: Before drug administration and in the following determined timepoints after drug administration in each period: 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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