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In-vivo Bioequivalence Study of Regorafinib 40 mg FC. Tablets of the Test Drug (FENOSA® 40 mg FC. Tabs, Nano Alvand, Iran)

In-vivo Bioequivalence Study of Regorafinib 40 mg FC. Tablets of the Test Drug (FENOSA® 40 mg FC. Tabs, Nano-Alvand, Iran) in Compared with the Reference Drug (STIVAGRA® 40 mg Tabs, Buyer, Germany) In Iranian Healthy Volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N120
Enrollment
24
Registered
2024-09-07
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

This study is performed on healthy volunteers and drug concentration in plasma is determined..

Interventions

Control group: Intervention group: single dose, one oral tablet (STIVAGRA® 40 mg, Buyer) as a reference product. after washout period, the volunteers received Regorafinib 40 mg FC. Tablets manufacture

Sponsors

Nanoalvand Pharmaceutical Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Regorafinib

Design outcomes

Primary

MeasureTime frame
Drug plasma concentration. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10,12, 24, 48 and 72 hours after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.—

Secondary

MeasureTime frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.—

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