At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-label, Randomized, Three-period, Crossover, Partial Replicated, Reference-scaled, Single Center Trial to Assess the Bioequivalence of a Single Oral Dose of 1200 mg of the New Cisticid 600 mg Tablet Formulation Versus Comparator Biltricide in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating Cisticid and Biltricide for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of this trial is to assess the bioequivalence (BE) of new 600 milligram (mg) Cisticid tablet (Test) versus 600 mg Biltricide tablets (Reference) at a dose of 1200 mg in healthy male participants. Praziquantel (PZQ) is the active ingredient for Cisticid and Biltricide tablets.
Study Details
Timeline
Interventions
Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).