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Comparative bioequivalence study of the Eltrombopag 50 mg Tablet Manufactured by Actero Middle East Pharmaceutical Company

Comparative Bioequivalence Study of the Eltrombopag 50 mg Tablet Manufactured by Actero Middle East Pharmaceutical Company by Innovative Company

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231108059993N9
Enrollment
24
Registered
2025-11-18
Start date
2025-11-16
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 volunteers were enrolled in the study.

Interventions

Intervention group: Intervention group: The first intervention group, which has been randomly and double-blindly selected, will take the Iranian Eltrombopag 50 mg tablets, and the second group will t

Sponsors

Actero Middle East Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Good general health (liver, heart, and kidneys) Body mass index (18-28) Informed consent Age (18-60 years)

Exclusion criteria

Exclusion criteria: Addiction to alcohol, drugs and cigarettes Sensitivity to Eltrombopag Chronic disease treatment history

Design outcomes

Primary

MeasureTime frame
Drug Plasma Concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72. Method of measurement: Liquid chromatography with dual mass spectrometer (LC/M?S/MS).

Secondary

MeasureTime frame
Drug Plasma Concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72. Method of measurement: Liquid chromatography with dual mass spectrometer (LC/M?S/MS).;Drug Plasma Concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72. Method of measurement: Liquid chromatography with dual mass spectrometer (LC/M?S/MS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ghanbarzadeh

Tabriz University of Medical Sciences

s_ghanbarzadeh@yahoo.com+98 41 3383 2649

Outcome results

None listed

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