Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT00651534
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.
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?: