NCT05125627

Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Joint Stock Company "Farmak" · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)	Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator
DRUG	Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)	Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Timeline

• Start date: 2019-08-28
• Primary completion: 2019-10-21
• Completion: 2019-10-21
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Jordan