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Bioequivalence study of eltrombopag 50 mg tablet

Bioequivalence study of eltrombopag 50 mg tablet manufactured by Nanodaru Co versus originator brand (Revolade 50 mg) manufactured by Novartis Co. in fasting condition in healthy volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N109
Enrollment
24
Registered
2024-06-29
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-22

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

Intervention 1: Intervention group: single dose, one oral tablet Revolade 50 mg manufactured by Novartis Co. as a reference product. after washout period, the volunteers received Eltrombopag 50 mg ta

Sponsors

Nanodaru Company
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 (18-28) 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 eltrombopag

Design outcomes

Primary

MeasureTime frame
Drug plasma concentration. Timepoint: 0, 1, 12, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 h 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.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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