Bioequivalence of Ulipristal Acetate 30 mg Tablets: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting Conditions.
interventional
N/A
1 country
1
To demonstrate bioequivalence between Test and Reference products under fasting conditions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2023
Actual (reported)Cmax and AUC0-72 of ulipristal acetate will be the primary pharmacokinetic parameters for the bioequivalence assessment.
Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
ULIPRISTAL ACETATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
ULIPRISTAL ACETATE
Named ingredient: ulipristal acetate
View registry recordBlueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, 4250-449, Portugal
Amparo Amilburu
First Submitted
March 23, 2023
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Contact the study team to confirm eligibility.