Skip to content

Comparative bioequivalence study of the Eltrombopag 50 mg Tablets, Manufactured by Daroo Darman Arang Pharmaceutical Company

Comparative bioequivalence Study of the Eltrombopag 50 mg Tablets, Manufactured by Arang Daroo Darman Pharmaceutical Company by Innovative Company (Revolade)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231108059993N8
Enrollment
24
Registered
2025-10-23
Start date
2025-11-05
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Healthy volunteer.

Interventions

Intervention 1: Intervention group 1 receives an Iranian drug and blood concentrations are obtained at specific time intervals. In the second series, this group receives the brand name drug. Intervent

Sponsors

Arang Daroo Darman
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Must be in good general health (liver, heart, and kidneys). Body mass index should be in the range of 18-28. Informed consent must be obtained. Age must be between 18-60 years.

Exclusion criteria

Exclusion criteria: History of allergic or adverse reaction to eltrombopag or any similar product. Addiction to cigarettes, alcohol, or any type of drug Volunteers with a history of chronic diseases such as high blood pressure or high blood lipids, etc. who have taken medication in the past two months.

Design outcomes

Primary

MeasureTime frame
At specific intervals, the blood concentration of the drug is measured and compared in two series of blood draws, and it is determined whether the drugs are equivalent or not. Timepoint: Drug concentrations are measured at time intervals of 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after drug administration. Method of measurement: Liquid chromatography with dual mass spectrometer LC/MS/MS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Phayesh Daroo Zist Azma

s_ghanbarzadeh@yahoo.com+98 41 3383 2649

Outcome results

None listed

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