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Bioequivalence Study of Sorafenib Tablet and Nexavar

Fasting Clinical Trial

Official title:
Randomized, Open-label, 3-way Reference Replicated Crossover Bioequivalence Study of Sorafenib 200 mg Tablet and Nexavar (Reference) Following a 200 mg Dose in Healthy Subjects Under Fasting Conditions

Clinical Trial Summary

Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.

Clinical Trial Description

This will be a single centre, bioequivalence, open-label, randomized, single-dose, 3-period, 3-sequence, reference replicated, crossover study. 36 healthy adult males or non-childbearing potential females, ≥18 and ≤65 years of age, smoker and/or non-smoker. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02599337
Study type Interventional
Source Yabao Pharmaceutical Group
Contact
Status Completed
Phase Phase 1
Start date July 2015
Completion date October 2015
View Details
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