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Clinical trial

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Darfen 400, 400 mg Ibuprofen Coated Tablets (512 mg Ibuprofen Sodium Dihydrate) Versus Nurofen® Forte Express, 400 mg Ibuprofen Coated Tablets (512 mg Ibuprofen Sodium Dihydrate) in Healthy Adult Male and Female Subjects Under Fasting Conditions

NCT05663398 is registered in ClinicalTrials.gov with Darnitsa Pharmaceutical Company as lead sponsor.

NCT NCT05663398
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Registry record

As filed in ClinicalTrials.gov.

Title
Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Darfen 400, 400 mg Ibuprofen Coated Tablets (512 mg Ibuprofen Sodium Dihydrate) Versus Nurofen® Forte Express, 400 mg Ibuprofen Coated Tablets (512 mg Ibuprofen Sodium Dihydrate) in Healthy Adult Male and Female Subjects Under Fasting Conditions
Lead sponsor
Darnitsa Pharmaceutical Company
Phase
Phase 1
Overall status
Completed
Start date
May 17, 2022
Completion date
May 31, 2022
Enrollment
32 (actual)
Sites
1

Conditions

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

bioequivalence, healthy subjects