In-Vivo Bioequivalence study of Naltrexone intramuscular injection in healthy Iranian volunteers

In-Vivo Bioequivalence study of Naltrexone intramuscular injection 380mg of Nano Daru Pajouhan Pardis (EXOPIO® 380mg) with brand drug (VIVITROL® 380mg, Alkermas Pharma, Ireland).

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N22

Enrollment

Registered

2021-01-19

Start date

2020-10-05

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

bioequivalence of test and reference drugs.

Interventions

Intervention 1: The intervention group: receives one test ampoule (Exopio of Nano Daroo Pajohan Pardis Pharmaceutical Company Contains 380 mg of naltroxane) as intramuscular injection. Blood samples w

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body Mass Index (BMI) between 18-28 Informed consent Age between 18-60 Both male and female

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Blood concentration of the drug. Timepoint: 1,2,4,8,12,24,36,48,60,72,168,240,336,432,576,720 hours after intervention (drug receiving). Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.	—

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