Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT02538393
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of Sorafenib Tablet for Oral Suspension
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
An Open Label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of Sorafenib Tablet for Oral Suspension Compared to Marketed Tablet and to Investigate the Pharmacokinetics of Sorafenib Tablet for Oral Suspension Including Food Effect and Dose Proportionality
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to
• Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.
The secondary objectives of this study are to
* Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state
* Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)
* Evaluate the taste and palatability of sorafenib (both formulations)
* Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects
• Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.
The secondary objectives of this study are to
* Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state
* Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)
* Evaluate the taste and palatability of sorafenib (both formulations)
* Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-002083-16 | EUDRACT_NUMBER | None | View |