Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 10:11 PM
Study NCT ID:
NCT01073904
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2010-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-04
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:
LEVEQ-3
Brief Summary:
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
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?: