Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers

NCT04414254 | Completed Phase 1 DMC

• 1 other identifier: QL-YK1-036-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• the ratios of geometrical mean

  The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.

  71 Days

Secondary Outcomes (1)

• the occurrence rate of adverse events

  71 Days

Study Arms (2)

conference-Cefprozil for Suspension®

EXPERIMENTAL

"Cefprozil for Suspension®" (125mg/5ml, 50ml/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.)

Drug: Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)

test-cefprozil granule

EXPERIMENTAL

cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd)

Drug: Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)

Interventions

Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg) DRUG

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.

conference-Cefprozil for Suspension®; test-cefprozil granule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female aged between 18 and 55 years old (including the critical value).
• The body mass index is in the range of 19-28 kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
• Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements, and laboratory safety tests .
• The subjects have no family planning within 6 months and could select contraceptive method.
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
• The subjects could complete the study accorrding to the protocol.

You may not qualify if:

• any history of hypersensitivity, needlesickness or idiosyncratic reactions to any food or drug, especially for penicillins or cephalosporins;
• hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
• any history of acute or chronic illness that might affect drug absorption, and/or metabolism;
• positive results for urine drug screening;
• any history of drug abuse in the past 5 years or drug use 3 months prior to screening;
• any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
• smoking more than 5 cigarettes per day during the 3 months prior to screening;
• blood donation, massive blood loss (\>400mL) or enrolled in other clinical trials 3 months prior to screening;
• any use of other prescription drugs (including contraceptive) 14 days prior to medication for this study;
• any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol products, grapefruit-containing or caffeine/xanthine-rich foodand beverages 48 h prior to medication for this study;
• the outcome of breath alcohol test \> 0mg /mL;
• dysphagia or having special dietary requirements;
• occurring acute disease in the screening period or before the medication;
• lactating or pregnant women;
• investigator-determined ineligibility.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Related Publications (1)

• Lin PP, Wang CJ, Liu YP, Li T, Gao XM, Ma YP, Shi P, Li X, Wang LX, Cao Y. Pharmacokinetics and Bioequivalence of Cefprozil for Suspension and Granule Formulation in Healthy Chinese Volunteers: Two Single-Dose Crossover Studies. Adv Ther. 2021 Feb;38(2):1130-1142. doi: 10.1007/s12325-020-01593-7. Epub 2020 Dec 19.

  PMID: 33340343 DERIVED

MeSH Terms

Interventions

Cefprozil; Suspensions

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yu Cao, Doctor

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label, randomized, single-dose, two-period, two-group, crossover study.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: September 11, 2018
• Primary Completion: November 22, 2018
• Study Completion: January 30, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)