A bioequivalence study of Niloitinib 150mg capsule of Sobhan Oncology compared to Tasigna 150 mg capsule manufactured by Novartis in 24 healthy volunteers under fasting condition

A cross over bioequivalence study of Niloitinib 150mg capsule of Sobhan Oncology compared to Tasigna 150 mg capsule manufactured by Novartis in 24 healthy volunteers under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220209053979N4

Enrollment

Registered

2022-08-09

Start date

2022-09-06

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Investigation of bioequivalence of Nilotinib 150 mg capsule manufactured by Sobbhan Oncology company in comparison to the Tagigna150 mg capsule manufactured by Novartis company.

Interventions

Intervention 1: Intervention group 1: Oral administration of a 150 mg capsule manufactured by Sobhan Oncology Company to 12 healthy volunteers in fasting condition with 240 ml of water. Then 14 blood

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects Body mass index (BMI) >18 but <30. Laboratory parameter values must fall within the normal range

Exclusion criteria

Exclusion criteria: Smokers History of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of Nilotinib of Sobhan Oncology and Tasigna manufactured by Novartis Company. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 h. Method of measurement: liquid chromatography mass spectrometry (LCMSMS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Talari

Kharazmi Plasma Center

talari_r@yahoo.com+98 21 5669 4726

Outcome results

None listed

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