Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-03-06 @ 1:17 PM
Study NCT ID:
NCT03309566
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir
Sponsor:
Laboratorio Elea Phoenix S.A.
Organization:
Study Overview
Official Title:
Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A
Status:
COMPLETED
Status Verified Date:
2017-10
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:
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: