NCT05125640

Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects

Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single Oral Dose, Crossover Bioequivalence Study of Progesterone 200 mg Soft Capsule vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 single oral dose of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Versus Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) 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 postmenopausal female subjects under fasting conditions. During each period 26 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, 2.33, 2.67, 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, 48.00, 72.00 and 96.00 hours after dosing. Mode of administration: Orally, with 240 mL of water at dosing in sitting position Bioequivalence Acceptance Criteria: ▲Cmax (Maximum plasma concentration): Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the variance of σw2 within subject variability for the reference based on corrected progesterone. AUC0-last (the area under the plasma concentration-time curve): The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on corrected Progesterone. ▲Based on Cmax CVR% (Coefficient of Variation Ratio )=50.97% the calculated confidence interval acceptance limits were (69.83%-143.19%)

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)	Orally, with 240 mL of water at dosing in sitting position
DRUG	Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)	Orally, with 240 mL of water at dosing in sitting position

Timeline

• Start date: 2019-12-13
• Primary completion: 2020-01-07
• Completion: 2020-01-07
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Jordan