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Clinical trial

Single-dose, Randomized, Two-period, Two-sequence Crossover Study to Evaluate the Bioequivalence of Lepsiramp 0.5mg/ml Oral Suspension (Test) and Fycompa® 0.5mg/ml Oral Suspension (Reference) Under Fasting Conditions

NCT06969963 is registered in ClinicalTrials.gov with Aya Mohammed Abdel Magid Abdel Hamid as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
Single-dose, Randomized, Two-period, Two-sequence Crossover Study to Evaluate the Bioequivalence of Lepsiramp 0.5mg/ml Oral Suspension (Test) and Fycompa® 0.5mg/ml Oral Suspension (Reference) Under Fasting Conditions
Lead sponsor
Aya Mohammed Abdel Magid Abdel Hamid
Phase
Phase 1
Overall status
Completed
Start date
March 7, 2024
Completion date
July 23, 2024
Enrollment
26 (actual)
Sites
1

Conditions

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

bioequivalence study in healthy subjects