# Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers

## TL;DR

This study compared the bioequivalence and safety of two ibuprofen/phenylephrine combination tablets in healthy Chinese volunteers under fasting and fed conditions.

## Contribution

The study provides evidence of bioequivalence and similar safety profiles of two ibuprofen/phenylephrine FDC tablets in Chinese adults.

## Key findings

- The geometric mean ratios for Cmax, AUC0–t, and AUC0–∞ of both drugs were within the 80%–125% bioequivalence range in both fasting and fed states.
- Reference-scaled average bioequivalence (RSABE) was applied for phenylephrine Cmax due to high variability.
- Both products were well tolerated with mild and comparable adverse events.

## Abstract

This single‐center, randomized, open‐label bioequivalence program compared two fixed‐dose combination (FDC) tablets containing ibuprofen (200 mg) and phenylephrine hydrochloride (10 mg) from different manufacturers in healthy Chinese adults under fasting and fed conditions. A three‐period, partially replicated crossover design was used for the fasting study and a four‐period, fully replicated crossover design for the fed study. Serial plasma samples were collected up to 16 h post‐dose, and pharmacokinetic parameters included Cmax, AUC0–t, and AUC0–∞ for both analytes. Bioequivalence was assessed using average bioequivalence (ABE) when the within‐subject standard deviation of the reference was <0.294 and reference‐scaled ABE (RSABE) otherwise. The geometric mean ratios (90% CIs) for Cmax, AUC0–t, and AUC0–∞ of both ibuprofen and phenylephrine fell within 80%–125% in both nutritional states, with RSABE applied to phenylephrine Cmax where variability was high. Both products were well tolerated; adverse events were mild, comparable between test and reference, and no subject discontinued due to adverse events. These findings demonstrate bioequivalence of the two ibuprofen/phenylephrine FDC and support their similar safety profiles in healthy Chinese volunteers.