- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414254
Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers
June 1, 2020 updated by: The Affiliated Hospital of Qingdao University
Bioequivalence of Cefprozil for Suspension and Granule Formulation in Healthy Chinese Volunteers: Two Single-Dose Crossover Studies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266003
- Phase I Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: conference-Cefprozil for Suspension®
"Cefprozil for Suspension®" (125mg/5ml, 50ml/bottle, batch no.
F701087, manufactured by Lupin Pharmaceuticals, Inc.)
|
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.
|
Experimental: test-cefprozil granule
cefprozil granule (125mg, batch no.
8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the ratios of geometrical mean
Time Frame: 71 Days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the occurrence rate of adverse events
Time Frame: 71 Days
|
Adverse events were recorded to evaluate the safety of the studied drugs.
|
71 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2018
Primary Completion (Actual)
November 22, 2018
Study Completion (Actual)
January 30, 2019
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QL-YK1-036-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center.
The research center can not publish any academic papers without the consent of the sponsor.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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