NCT02599337

Bioequivalence Study of Sorafenib Tablet and Nexavar

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Yabao Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Nexavar	Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.
DRUG	Sorafenib	Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-11-06
• Last updated: 2015-11-06

Locations

1 site across 1 country: Canada