A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet

• Status: Withdrawn
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

• A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.

• A Healthy female volunteers, aged 19-45 years

• BMI 18 ~ 27(kg/m2)

Exclusion Criteria:

• History or presence of clinically significant medical or psychiatric condition or disease.

• History of gastrointestinal disease and resection

• History of clinically significant hypersensitivity to study drug, any other drug

• A subject with clinically significant genital bleeding

• Participation in any other study within 3 months

• Positive results for urine β-hCG in screening or lactating women

• A subject is using a method of hormone contraception and a Progesterone intrauterine device