NCT05663398

Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Darnitsa Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets \[512 mg ibuprofen sodium dihydrate\], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and Reference medicinal product (marketed medicinal product Nurofen® Forte Express, 400 mg ibuprofen coated tablets \[512 mg ibuprofen sodium dihydrate\], manufactured by Reckitt Benckiser \[Poland\] S.A.) in healthy volunteers.

Conditions

• Bioequivalence
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Darfen 400, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)	Oral, a nonsteroidal anti-inflammatory drug
DRUG	Nurofen® Forte Express, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)	Oral, a nonsteroidal anti-inflammatory drug

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: Jordan