NCT05800106

A Bioequivalence Study of Sunitinib Malate Capsules.

A Bioequivalence Study of Sunitinib Malate Capsules in Healthy Volunteers Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.

Conditions

• Gastrointestinal Stromal Tumors
• Renal Cell Carcinoma
• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Sunitinib malate capsules generic product	Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
DRUG	Sunitinib malate capsules reference product	Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).

Timeline

• Start date: 2018-12-04
• Primary completion: 2019-01-06
• Completion: 2019-01-12
• First posted: 2023-04-05
• Last updated: 2023-04-10

Locations

1 site across 1 country: China