NCT05125627View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 28, 2019

Primary Completion Date

October 21, 2019

Study Completion Date

October 21, 2019

Conditions
Pharmacokinetics
Interventions
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

Trial Locations (1)

11910

Arab Pharmaceutical Industry Consulting/Pharmaceutical Research Unit, Amman

All Listed Sponsors
lead

"Joint Stock Company Farmak"

INDUSTRY

NCT05125627 - Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route | Biotech Hunter | Biotech Hunter