study on Ulipristal Acetate 30 mg Tablets on healthy female subjects to compare the plasma concentrations between test product and marketed product

Phase 1

Completed

• Registration Number: CTRI/2009/091/000518
• Lead Sponsor: HRA Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

Healthy, female subjects 18 to 35 years of age (inclusive).
· Body mass within 10% of the ideal mass in relation to height and age, according to the
BMI (normal range for BMI: 18.5 ? 25 kg/m2)
· Regularly menstruating women: cycles of 28±3 days duration
· No current use of hormonal contraception and having had at least one complete
menstrual cycle (2 menses) since having stopped hormonal contraception
· Willing to not use hormonal methods of contraception until study completion
· At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
· Able to read and give voluntary, written informed consent, and agree to observe all
study requirements (the subject needs to be available for follow-up over the next 6
weeks)
· Willing to abstain from any acts of unprotected intercourse or having a valid nonhormonal
IUD in place during participation in the study
· Non-smoker

Exclusion Criteria

Evidence of psychiatric disorder, antagonist personality, poor motivation, emotional or
intellectual problems likely to limit the validity of consent to participate in the study or limit
the ability to comply with protocol requirements
· History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to
other substances of abuse.
· Use of any medication, prescribed or over-the-counter, within two weeks prior to the first
administration of study medication except if this will not affect the outcome of the study in
the opinion of the investigator.
Protocol 2914-011
DRD_FO_GB_037_03 VERSION: 1.1 ? Date: 2009-02-03 15
· Impaired hypothalamic-pituitary-adrenal reserve.
· Participation in another study with an experimental drug within eight weeks before the first
administration of study medication. Participation to more than 3 experimental drug studies
within 12 months before the beginning of the study.
· A major illness during the three months before commencement of the screening period.
· Undiagnosed genital bleeding.
· Relevant history or laboratory or clinical findings indicative of acute or chronic disease,
likely to influence the study outcome.
· Donation or loss of blood equal to or exceeding 500 mL during the eight weeks before the
first administration of study medication. Donation of more than 1.5 L of blood within the 10
months before the beginning of the study.
· Diagnosis of hypertension made during the screening period or current diagnosis of
hypertension.
· Resting pulse rate of > 100 beats per minute or < 45 beats per minute during the screening
period, either supine or standing.
· Currently pregnant as confirmed by positive urine pregnancy test (b-HCG) either positive or
not performed or lactation
· Currently breast-feeding
· Current use of hormonal contraception
· Current use of progesterone intrauterine device (IUD)
· Positive urine screen for drugs of abuse

Study & Design

• Study Type: BA/BE
• Study Design: Not specified