NCT02852681

Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers

A Study to Characterize the Effect of Food on the Bioavailability of 15 mg Estetrol (E4)/3 mg Drospirenone (DRSP) Tablets in Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.

Detailed description

Food effect bioavailability studies are usually conducted for new drugs and drug products to assess the effect of food on the rate and extent of absorption of a drug when the drug product is administered shortly after a meal (fed conditions), as compared to administration under fasting conditions. Therefore, this study was designed to characterize the effect of a high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet containing 15 mg E4 and 3 mg DRSP. All subjects entered the study site at least 12 hours before each dosing and fasted for at least 10 hours prior to each dose. All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food (fed)) either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects were randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	15 mg E4/3 mg DRSP	All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2016-08-02
• Last updated: 2016-08-02