To Determine Bioequivalence Under Fasting ConditionsPhase 1NCT00652795
Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions
A Phase 1 study testing Doxycycline Monohydrate and Monodox in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc. at 1 site in Canada.
Trial summary
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fasting Conditions
- What is being tested?
- Doxycycline Monohydrate and Monodox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2004to Sep 2004
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-childbearing potential female, smoker or non-smokers
- 18 years of age and older
- Non-childbearing potential female subjects is defined as post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration
- Capable of consent
Who cannot join
- Clinically significant illnesses within 4 weeks of the administration of study medication
- Clinically significant surgery within 4 weeks prior to the administration of the study medication
- Any clinically significant abnormality found during medical screening
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
- Abnormal laboratory tests judged clinically significant
- Positive testing for hepatitis B, hepatitis C or HIV at screening
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- ECG abnormalities or vital sign abnormalities at screening
- BMI greater than or equal to 30.0 kg/m2
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week
- History of drug abuse or use of illegal drugs: soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit or positive urine drug screen at screening
- History of allergic reactions to heparin, doxycycline, or other related drugs
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
- Use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption
- Difficulty to swallow study medication
- Smoking more than 25 cigarettes per day Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in the study A depot injection or an implant of any drug within 3 months prior to administration of study medication
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study)prior to the administration of the study medication (50 mL to 300 mL of whole blood within 30 days, 301 mL to 500 mL of whole blood within 45 days, or more than 500 mL of whole blood within 56 days prior to drug administration)
- History or presence of clinically significant gastro-oesophageal reflux, stomach ulcers, or indigestions
- History or presence of clinically significant severe renal or hepatic dysfunction
- History or presence of clinically significant myasthenia gravis
- Breast-feeding subject
- Positive urine pregnancy screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
Read the detailed description
To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.
- Being tested
- Doxycycline Monohydrate, Monodox
- Keywords
- bioequivalence, doxycycline monohydrate, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline MonohydrateDrug
Also called Monodox
Tablets, 150 mg, single-dose
MonodoxDrug
Also called Doxycycline Monohydrate
Capsules 50 mg (3 x 50 mg dose), single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions. Receives: Drug: Doxycycline Monohydrate |
| B | Active comparator | Subjects received the Oclassen's product (Monodox) Capsules under fasting conditions. Receives: Drug: Monodox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJul 2004
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fasting ConditionsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Investigators
- Benoit Girard, M.D., Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652795
- Sponsor's protocol ID
- 40074
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00652795
- Acronym / sponsor ID
- 40074
- Keywords
- bioequivalence, doxycycline monohydrate, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Study start
- Jul 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 4 Apr 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.
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
Detailed description
To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Doxycycline MonohydrateSubjects received the Par product (Doxycycline Monohydrate) under fasting conditions. |
| B | Active comparator | Drug: MonodoxSubjects received the Oclassen's product (Monodox) Capsules under fasting conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-childbearing potential female, smoker or non-smokers
- 18 years of age and older
- Non-childbearing potential female subjects is defined as post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration
- Capable of consent
Key exclusion criteria (24 listed)
- Clinically significant illnesses within 4 weeks of the administration of study medication
- Clinically significant surgery within 4 weeks prior to the administration of the study medication
- Any clinically significant abnormality found during medical screening
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
- Abnormal laboratory tests judged clinically significant
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 MonohydrateAlso: MonodoxTablets, 150 mg, single-dose | Drug | A |
| MonodoxAlso: Doxycycline MonohydrateCapsules 50 mg (3 x 50 mg dose), single-dose | Drug | B |
Primary outcome
Rate and extent of absorption
Time frame: 24 hours
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 4 Apr 2008.
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.
Benoit Girard, M.D. principal investigator
Anapharm
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 Doxycycline Monohydrate and Monodox in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc. 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 4 inclusion and 24 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 4 Apr 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.
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?
Rate and extent of absorption (time frame: 24 hours). 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 4 Apr 2008.