Anti-Infective AgentsPhase 1NCT01073553
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
A Phase 1 study testing Cephalexin capsules (Optocef, BAYO5448 ) and Cephalexin capsules (Keflex) in people with Anti-Infective Agents, run by Bayer at 1 site in Mexico.
Trial summary
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-Infective Agents
- What is being tested?
- Cephalexin capsules (Optocef, BAYO5448 ) and Cephalexin capsules (Keflex)
- 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 siteMexico
- Study dates
- Oct 2009to Oct 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis
Who cannot join
- History of illnesses or any organic abnormalities that could affect the results of the study
- History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
- Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.
- Conditions
- Anti-Infective Agents
- Being tested
- Cephalexin capsules (Optocef, BAYO5448 ), Cephalexin capsules (Keflex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalexin capsules (Optocef, BAYO5448 )Drug
Single dose of 500 mg (One 500 mg capsule)
Cephalexin capsules (Keflex)Drug
Single dose of 500 mg (Two 250 mg capsules)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Cephalexin capsules (Optocef, BAYO5448 ) |
| Arm 2 | Active comparator | Not described Receives: Drug: Cephalexin capsules (Keflex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least square estimator of average maximum plasmatic concentration (log transformed)
Measured: After two months
Least square estimator of area under the pharmacokinetic curve (log transformed)
Measured: After two months
Secondary outcomes (5)
Time at which maximum concentration is reached
Measured: After two months
Area under the pharmacokinetic curve from time=0 to last blood sample
Measured: After two months
Clearance constant of plasmatic concentration of study drug
Measured: After two months
Half life of plasmatic concentration of study drug
Measured: After two months
Adverse events collection
Measured: Up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Infective AgentsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Corporación Bonima S.A. de C.V.
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073553
- Sponsor's protocol ID
- 14784
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2010
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations
- ClinicalTrials.gov ID
- NCT01073553
- Acronym / sponsor ID
- 14784
- Conditions
- Anti-Infective Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Corporación Bonima S.A. de C.V.
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Feb 2010 (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.
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Cephalexin capsules (Optocef, BAYO5448 ) |
| Arm 2 | Active comparator | Drug: Cephalexin capsules (Keflex) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis
Key exclusion criteria (3 listed)
- History of illnesses or any organic abnormalities that could affect the results of the study
- History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
- Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
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 |
|---|---|---|
| Cephalexin capsules (Optocef, BAYO5448 )Single dose of 500 mg (One 500 mg capsule) | Drug | Arm 1 |
| Cephalexin capsules (Keflex)Single dose of 500 mg (Two 250 mg capsules) | Drug | Arm 2 |
Primary outcome
Least square estimator of average maximum plasmatic concentration (log transformed)
Time frame: After two months
Least square estimator of area under the pharmacokinetic curve (log transformed)
Time frame: After two months
5 secondary outcomes
Time at which maximum concentration is reached
Time frame: After two months
Area under the pharmacokinetic curve from time=0 to last blood sample
Time frame: After two months
Clearance constant of plasmatic concentration of study drug
Time frame: After two months
Half life of plasmatic concentration of study drug
Time frame: After two months
Adverse events collection
Time frame: Up to six weeks
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 3 Apr 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cephalexin capsules (Optocef, BAYO5448 ) and Cephalexin capsules (Keflex) in people with Anti-Infective Agents, run by Bayer at 1 site in Mexico.
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 3 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 3 Apr 2015. 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 Mexico. 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.
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?
Least square estimator of average maximum plasmatic concentration (log transformed) (time frame: After two months). The study lists 2 primary outcomes in all. 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 3 Apr 2015.