NCT04414254

Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers

Bioequivalence of Cefprozil for Suspension and Granule Formulation in Healthy Chinese Volunteers: Two Single-Dose Crossover Studies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition) to assess the bioequivalence between two formulations of cefprozil.

Detailed description

Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum of antimicrobial activity. A granule formulation has been developed to improve medication adherence of the patients. This study was conducted to assess the bioequivalence of the granule formulation to dry suspension in healthy Chinese volunteers and estimate the pharmacokinetics profiles of cefprozil. An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition) to assess the bioequivalence between two formulations of cefprozil. Blood samples were collected at specified time intervals, and the plasma concentrations of cis- and trans-cefprozil were determined by a validated liquid chromatography- mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability parameters were estimated via non-compartmental methods. Adverse events were also recorded. If the 90% confidence intervals of the ratios of geometrical mean of test and reference formulations for Cmax, AUC0-t and AUC0-infer are all within the predefined bioequivalence criteria range of 80%-125% for cis-, trans-and total cefprozil, the two formulations can be considered bioequivalent.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)	Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods."Cefprozil for Suspension®" (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.

Timeline

• Start date: 2018-09-11
• Primary completion: 2018-11-22
• Completion: 2019-01-30
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

1 site across 1 country: China