To Determine Bioequivalence Under Fed ConditionsPhase 1NCT01380496
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
A Phase 1 study testing doxycycline monohydrate in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg. 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
- To Determine Bioequivalence Under Fed Conditions
- What is being tested?
- doxycycline monohydrate
- 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 siteCanada
- Study dates
- Nov 1999to Nov 1999
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, non-smokers, between 18-55 years of age
- Subjects' weight will be within 15% of their ideal weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983.
- Subjects should read, sign, and date an Informed Consent Form prior to any study procedures
- Subjects must complete all screening procedures within 28 days prior to the administration of the study medication.
Who cannot join
- Clinically significant abnormalities found during medical screening
- Any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Abnormal laboratory test judged clinically significant.
- ECG or vital signs abnormalities (clinically significant).
- History of allergic reactions to doxycycline or other related drugs (e.g., chlortetracycline, demeclocycline, minocycline and tetracycline).
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- History of allergic reactions to heparin.
- Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- Positive urine drug screen (see section VIII) at screening
- Positive testing for hepatitis B, hepatitis C or HIV screening.
- Use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication.
- Recent donation of plasma (500 mL) within 7 days or recent donation or significant loss of whole blood (450 mL) with 56 days prior to administration of the study medication.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)
- Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack) within 1 year of the screening visit.
- Subjects who have taken prescription medication 14 days preceding administration of study medication or over the counter products 7 days preceding administration of study medication, except for topical products without systemic absorption.
- Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine).
- Subjects who have undergone clinically significant surgery 4 weeks prior to the administration of the study medication.
- Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 3-Way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA)(Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg In Healthy Adult Males Under Fasting and Fed Conditions
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
Read the detailed description
To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fed and fasting conditions.
- Being tested
- doxycycline monohydrate
- Keywords
- bioequivalence, doxycycline monohydrate, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline monohydrateDrug
Also called Monodox(R)
tablet, 100 mg, single, oral dose
doxycycline monohydrateDrug
Also called Monodox (R)
Capsule, 100 mg, single, oral dose
doxycycline monohydrateDrug
Also called Monodox(R)
Capsule, 100 mg, single, oral dose
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Subjects received the Oclassen Pharmaceuticals Inc. formulated product. Receives: Drug: doxycycline monohydrate |
| C | Active comparator | Subjects received the Oclassen Pharmaceuticals Inc. formulated product. Receives: Drug: doxycycline monohydrate |
| A | Experimental | Subjects received the Par formulated product Receives: Drug: doxycycline monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Comparable food effect; The ratio of least-squares meansof the test to reference of AUCo-t, AUC -inf and Cmax should be within 80% to 125%.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 1999
- Primary completionNov 1999
- Study completionNov 1999
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 Fed 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Investigators
- Eric Masson, Pharm D., Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380496
- Sponsor's protocol ID
- 99118
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2008
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 3-Way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA)(Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg In Healthy Adult Males Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT01380496
- Acronym / sponsor ID
- 99118
- Keywords
- bioequivalence, doxycycline monohydrate, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Study start
- Nov 1999
- Primary completion
- Nov 1999 (actual)
- Study completion
- Nov 1999 (actual)
- First posted
- 27 Jun 2011 (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 purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
Detailed description
To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fed and fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: doxycycline monohydrateSubjects received the Oclassen Pharmaceuticals Inc. formulated product. |
| C | Active comparator | Drug: doxycycline monohydrateSubjects received the Oclassen Pharmaceuticals Inc. formulated product. |
| A | Experimental | Drug: doxycycline monohydrateSubjects received the Par formulated product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males, non-smokers, between 18-55 years of age
- Subjects' weight will be within 15% of their ideal weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983.
- Subjects should read, sign, and date an Informed Consent Form prior to any study procedures
- Subjects must complete all screening procedures within 28 days prior to the administration of the study medication.
Key exclusion criteria (18 listed)
- Clinically significant abnormalities found during medical screening
- Any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Abnormal laboratory test judged clinically significant.
- ECG or vital signs abnormalities (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: Monodox(R)tablet, 100 mg, single, oral dose | Drug | A |
| doxycycline monohydrateAlso: Monodox (R)Capsule, 100 mg, single, oral dose | Drug | B |
| doxycycline monohydrateAlso: Monodox(R)Capsule, 100 mg, single, oral dose | Drug | C |
Primary outcome
Bioequivalence
Comparable food effect; The ratio of least-squares meansof the test to reference of AUCo-t, AUC -inf and Cmax should be within 80% to 125%.
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 26 Sep 2017.
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.
Eric Masson, Pharm 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 in people with To Determine Bioequivalence Under Fed 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 18 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 26 Sep 2017. 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?
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 26 Sep 2017.