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In-vivo Bioequivalence Study of Vinorelbine 30 mg Test Capsules (Sana Pharmed, Iran)

In-vivo Bioequivalence Study of Vinorelbine 30 mg Test (Sana Pharmed, Iran) and Reference Capsules (NAVELBIN® 30 mg, Pierre Fabre, France) In Iranian Volunteers with Breast Cancer.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N162
Enrollment
24
Registered
2025-12-05
Start date
2025-10-23
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

breast cancer patient.

Interventions

Intervention 1: First intervention group: Administration of a single oral dose of 30 mg soft gelatin capsule of vinorelbine (Sana Pharmed Pharmaceutical Co., Iran) in one period of a randomized two-pe

Sponsors

Sana pharmed
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: patients with breast cancer

Exclusion criteria

Exclusion criteria: Smoking Alcohol and drug abuse Abnormal liver or kidney function AIDS, HBV, HCV, syphilis Abnormal WBC, hemoglobin, or platelets History of acute or chronic GI, liver, kidney, or cardiovascular disease Candidates with a neutrophil count less than 500/mm3

Design outcomes

Primary

MeasureTime frame
Drug concentration in blood. Timepoint: 0.5? 1.0? 1.5? 2.0? 2.5? 3.0? 3.5? 4.0? 5? 6 ? 8? 10? 12? 24 ? 48, 72 hours after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

MeasureTime frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the instrumental analysis of the samples using the WinNonLin software developed by Phoenix Company.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time plots.

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