HealthyPhase 1NCT00882154
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
A Phase 1 study testing Cefdinir 300 mg Capsule (Sandoz, Austria) and Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) in people with Healthy, run by Sandoz.
Trial summary
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cefdinir 300 mg Capsule (Sandoz, Austria) and Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Apr 2005
- Phase
- Phase 1
- 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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Who cannot join
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
About this study
Official title: A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.
- Conditions
- Healthy
- Being tested
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Keywords
- Antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefdinir 300 mg Capsule (Sandoz, Austria)Drug
Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cefdinir 300 mg Capsule (Sandoz, Austria) Receives: Drug: Cefdinir 300 mg Capsule (Sandoz, Austria) |
| 2 | Active comparator | Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) Receives: Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUC and Cmax
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2005
- Study completionApr 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Larouche, M.D., Principal investigator, SFBC Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882154
- Sponsor's protocol ID
- 50039
- Status last verified
- Apr 2009
- First submitted
- 14 Apr 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State
- ClinicalTrials.gov ID
- NCT00882154
- Acronym / sponsor ID
- 50039
- Conditions
- Healthy
- Keywords
- Antibiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 16 Apr 2009 (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.
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)Cefdinir 300 mg Capsule (Sandoz, Austria) |
| 2 | Active comparator | Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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 |
|---|---|---|
| Cefdinir 300 mg Capsule (Sandoz, Austria) | Drug | 1 |
| Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) | Drug | 2 |
Primary outcome
Bioequivalence based on AUC and Cmax
Time frame: 7 days
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 29 Mar 2017.
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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.
Richard Larouche, M.D. principal investigator
SFBC Anapharm
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefdinir 300 mg Capsule (Sandoz, Austria) and Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA) in people with Healthy, run by Sandoz.
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 1 inclusion and 2 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 based on AUC and Cmax (time frame: 7 days). 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 29 Mar 2017.