Study of bioequivalence of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) and foreign samples on 24 healthy Iranian volunteers.

In- Vivo Bioequivalence study of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) with brand drugs (Stalevo 200/50/200mg Novartis, Germany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N9

Enrollment

Registered

2020-09-13

Start date

2020-09-24

Completion date

Unknown

Last updated

2020-10-06

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 Staperkin will be evaluated..

Interventions

Intervention 1: Intervention group: Single dose of levodopa / carbidopa / entocapone citalopram 200/200/200 mg tablets (TALEVO® 200/50 / 200mg. NOVARTIS, Germany) Pharmaceutical Company as a referenc

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health ( liver , heart , kidney ) Body mass index (18-28 ) Informed consent Age (18-60 )

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 drug concentration. Timepoint: Hour. Method of measurement: Blood sampling.	—

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