Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-07 @ 12:04 PM
Study NCT ID:
NCT03668860
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
India Dexamethasone and Betamethasone
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Randomized Study to Compare the Pharmacokinetics and Pharmacodynamics of Single Dose Dexamethasone and Betamethasone Administered Orally and Intramuscularly in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2020-07
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:
An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: