HealthyNCT00778245
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions
A study testing cefprozil 500mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cefprozil 500mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject candidates must fulfill all of the following inclusion criteria t be eligible for participation in the study, unless otherwise specified:
- Healthy adult male or female volunteers, 18 to 55 years of age
- Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
- Medically healthy subjects with clinically normal laboratory profiles and ECGs
- Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
Show all 11Show fewer
- IUD in place for at least 3 months
- Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
- Hormonal contraceptives for at least 3 months prior to the first dose of the study
- Other birth control methods may be deemed acceptable e) Post menopausal women with amenorrhea for at least 2 years will be eligible f) Voluntarily consent to participate in the study
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- In addition, history or presence of:
- alcohol or drug abuse within the past year
- hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin c) Female subjects who are pregnant or lactating d) Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study e) Subjects who through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days
- 1500 mL of blood in 180 days
- 2500 mL of blood in 1 year f) Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open - Label, Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg Cefprozil Tablets in Healthy Adult Volunteers Under Fed Conditions.
The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
Read the detailed description
A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.
Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.
- Conditions
- Healthy
- Being tested
- cefprozil 500mg tablets
- Keywords
- Bioequivalence cefprozil 500mg tablets fed conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefprozil 500mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | cefprozil 500mg tablets of Ranbaxy Receives: Drug: cefprozil 500mg tablets |
| 2 | Active comparator | CEFZIL ® 500 mg tablets of Bristol-Myers Squibb Company, USA Receives: Drug: cefprozil 500mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startMay 2005
- Primary completionJun 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778245
- Sponsor's protocol ID
- AA27169
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open - Label, Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg Cefprozil Tablets in Healthy Adult Volunteers Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT00778245
- Acronym / sponsor ID
- AA27169
- Conditions
- Healthy
- Keywords
- Bioequivalence cefprozil 500mg tablets fed conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
Detailed description
A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.
Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cefprozil 500mg tabletscefprozil 500mg tablets of Ranbaxy |
| 2 | Active comparator | Drug: cefprozil 500mg tabletsCEFZIL ® 500 mg tablets of Bristol-Myers Squibb Company, USA |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject candidates must fulfill all of the following inclusion criteria t be eligible for participation in the study, unless otherwise specified:
- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
- IUD in place for at least 3 months
- Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
Key exclusion criteria (8 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- alcohol or drug abuse within the past year
- hypersensitivity or idiosyncratic reaction to cefprozil, other cephalosporin antibiotics, or penicillin c) Female subjects who are pregnant or lactating d) Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study e) Subjects who through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days
- 1500 mL of blood in 180 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefprozil 500mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefprozil 500mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2008.