Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326697
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-11
Brief Title:
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia AML
Sponsor:
Hikma Pharmaceuticals LLC
Organization:
Hikma Pharmaceuticals LLC
Study Overview
Official Title:
A Randomized Single Oral Dose Open Label Two Sequence Two Treatment Four Periods Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia AML Under Fasting Conditions
Status:
RECRUITING
Status Verified Date:
2024-03
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:
A Randomized Single Oral Dose Open Label Two Treatment Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg 300 mg Film Coated Tablets in adult patients with AML under fasting conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None