NCT05737069

A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects

A Randomized, Open-label, Single-center, Single-dose, Two Treatment, Two-sequence, Two-period, Two-cohort, Two-way Crossover Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations.

Detailed description

The bioequivalence study adopts a single-center, randomized, open-label, single-dose, two-treatment, two-sequence, two-period, two-cohort, two-way crossover design with at least 2-day washout period, under both fasting and fed conditions in Chinese healthy adult participants. It will be planned to enroll approximately 84 participants out of which the first 34 participants for the fasted cohort and the subsequent 50 participants for the fed cohort receiving ibuprofen arginine granules 400 mg. Participants will be randomly assigned to either one of the 2 treatment (Test or Reference product) sequences in a 1:1 ratio within fasted cohort and fed cohort.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen arginine granules 400 mg	Experimental- Ibuprofen arginine granules 400 mg, one sachet administration containing 400 mg ibuprofen granules.
DRUG	Ibuprofen arginine granules 400 mg (Spedifen)	Marketed drug- Ibuprofen arginine granules 400 mg (Spedifen), one sachet administration containing 400 mg ibuprofen granules.

Timeline

• Start date: 2023-04-19
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2023-02-21
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: China