Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-02-09 @ 1:00 AM
Study NCT ID:
NCT03929861
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Two-treatment, Two-period, Two-sequence, Cross-over, Mono-center Bioequivalence Study to Compare Single Doses of Fluconazole 150 mg Capsule (Test Product) With Diflucan™ Capsule 150 mg (Reference) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Orca
Brief Summary:
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting conditions in order to assess bioequivalence Secondary Objectives: To assess safety and tolerability in form of adverse events and clinical parameters (systolic/diastolic blood pressure, pulse rate, body temperature, physical examination, electrocardiogram, clinical laboratory testing, and overall tolerability) and to assess further pharmacokinetic parameters of fluconazole
Detailed Description:
Clinical pharmacology
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-006159-13 | EUDRACT_NUMBER | None | View |