Bacterial InfectionPhase 4NCT00939562
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
A Phase 4 study testing doxycycline monohydrate tablet and doxycycline carragenate tablet in people with Bacterial Infection, run by Pfizer at 1 site in India.
Trial summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- doxycycline monohydrate tablet and doxycycline carragenate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
Who cannot join
- Evidence or history of clinically significant abnormality.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Conditions
- Bacterial Infection
- Being tested
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Keywords
- Bioequivalence
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline monohydrate tabletDrug
Tablet, 100 mg, Single dose
doxycycline carragenate tabletDrug
Tablet, 100 mg, Single dose
| Study group | Role | What they receive |
|---|---|---|
| doxycycline monohydrate tablet | Experimental | Not described Receives: Drug: doxycycline monohydrate tablet |
| doxycycline carragenate tablet | Active comparator | Not described Receives: Drug: doxycycline carragenate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Doxycycline
Measured: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939562
- Sponsor's protocol ID
- A1901003
- Status last verified
- Nov 2009
- First submitted
- 8 Jul 2009
- Last updated
- 23 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00939562
- Acronym / sponsor ID
- A1901003
- Conditions
- Bacterial Infection
- Keywords
- Bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 23 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxycycline monohydrate tablet | Experimental | Drug: doxycycline monohydrate tablet |
| doxycycline carragenate tablet | Active comparator | Drug: doxycycline carragenate tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant abnormality.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
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 |
|---|---|---|
| doxycycline monohydrate tabletTablet, 100 mg, Single dose | Drug | doxycycline monohydrate tablet |
| doxycycline carragenate tabletTablet, 100 mg, Single dose | Drug | doxycycline carragenate tablet |
Primary outcome
Maximum Plasma Concentration (Cmax) of Doxycycline
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing doxycycline monohydrate tablet and doxycycline carragenate tablet in people with Bacterial Infection, run by Pfizer at 1 site in India.
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 2 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 23 Dec 2009. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) of Doxycycline (time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.). 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 23 Dec 2009.