Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-07 @ 5:35 PM
Study NCT ID:
NCT02254434
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Open-label Single-dose Pharmacokinetic Study of an Oral Formulation in Tablets Containing Eltrombopag 50 mg (Revolade, Glaxosmithkline Mexico, S.A. De C.V.) in Healthy Volunteers Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2017-11
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:
This study evaluates pharmacokinetics of eltrombopag 50 mg after the oral administration in Mexican healthy volunteers under fasting conditions. The study will be an open label, single dose study with 26 subjects planned to be enrolled. Healthy subjects (male and female) aged between 18 - 50 years of age (inclusive) and a Body Mass Index within the range of 18-27.0 kg/meter (m)\^2 (inclusive) were enrolled according to Quetelet. REVOLADE is a registered trademark of the GSK group of companies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: