Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT05125627
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2021-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route
Sponsor:
Joint Stock Company "Farmak"
Organization:
Study Overview
Official Title:
Randomized, Two-sequence, Two-treatment, Four-period, Open Label, Single Dose, Crossover, Intravaginal Bioequivalence Study of 200 mg Soft Capsule Progesterone vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions.
Status:
COMPLETED
Status Verified Date:
2021-11
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:
This study was designed to assess the bioequivalence of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) versus Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) after a single Vaginal dose in healthy female subjects under fasting conditions.
Detailed Description:
An open-label, randomized, single dose, two-treatment, four-period, two-sequence, fully replicated crossover bioequivalence study with a washout period of 7 days in healthy female subjects under fasting conditions.Mode of administration:Intravaginally, the capsule introduced deeply into the vagina while lying down.During each period 25 blood samples were drawn 5 mL at (-1.00,-0.50,-0.137), before dosing and at 0.50, 1.00, 1.50, 2.00,2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00,36.00, 48.00, and 72.00 hours after dosing.
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?: