In-vivo Bioequivalence Study

In-vivo Bioequivalence study of Naltrexone 50 mg hard capsules of the test (Soroush-Mana Pharmed, Iran) in Compared with The brand drugs (ReVia 50 mg caps., Teva, USA) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N123

Enrollment

Registered

2024-09-21

Start date

2024-09-14

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

In this study the bioequivalence of test and brand of Naltrexone will be evaluated..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug (Naltrexone 50 mg hard capsules of Soroush-Mana Pharmed, Iran) in the first period. Intervention 2: Control group: Single-dose of the

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: After blood sampling. Method of measurement: HPLC-MS/MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Nemati

Radin shimi Co

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

Outcome results

None listed

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