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Clinical trial

An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest 100mg/2mL Solution for IM Injection With the Reference Product, Progesterone Injection, USP 500mg Per 10mL.

NCT07495007 is registered in ClinicalTrials.gov with Zi Diligence Biocenter as lead sponsor.

NCT NCT07495007
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest 100mg/2mL Solution for IM Injection With the Reference Product, Progesterone Injection, USP 500mg Per 10mL.
Lead sponsor
Zi Diligence Biocenter
Phase
Phase 1
Overall status
Completed
Start date
November 10, 2025
Completion date
December 28, 2025
Enrollment
26 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalance, post-menopause