HealthyPhase 1NCT00839072

Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers

A Phase 1 study testing Trazodone HCl in people with Healthy, run by Labopharm Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Trazodone HCl
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: Feb 2009to Mar 2009
Phase: Phase 1
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Availability for entire study period and willingness to adhere to protocol requirements as evidenced by signed informed consent
Male or female volunteer, aged between 18 and 45 years inclusively
BMI ≥20 and <30 kg/m2
Minimum body weight: 60 kg
Clinical laboratory values within normal range, or without clinical significance
Healthy according to medical history, clinical laboratory results and physical examination
Nonsmoker or ex-smoker

Who cannot join

Significant history of hypersensitivity to trazodone or any related products, or severe hypersensitivity reactions to any drugs
Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric disease
Use of MAO inhibitors within 28 days of day 1 of the study
Presence of significant heart disease or disorder according to ECG

Show all 18Show fewer

Seated systolic blood pressure lower than 90 or over 140 mmHg or diastolic blood pressure lower than 50 or over 90 mmHg at screening
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, and rifampin), in the previous 28 days before day 1 of this study
Females who are pregnant according to a positive serum pregnancy test, or are lactating
Females of childbearing potential who refuse to use an acceptable method of contraception from the screening visit and throughout the study
Volunteers who took an investigational product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc) in the previous 56 days before day 1 of the study
Positive urine screening for drugs of abuse
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive results to HIV, HBsAg, or anti-HCV tests

Trial locations and contacts

1 site in 1 country.

Canada1 site

Algorithme Pharma Inc.
Laval, Quebec, H7V 4B3

Other trials in Canada

About this study

Official title: Crossover Comparative Bioavailability Study of Trazodone Contramid(r) OAD 300 mg Extended-release Caplets and Desyrel(r) 100 mg Immediate-release Tablets in Healthy Adult Volunteers Under Fasting Conditions

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Read the detailed description

The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.

Conditions: Healthy
Being tested: Trazodone HCl
Keywords: bioavailability, pharmacokinetics, healthy, crossover, trazodone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trazodone HClDrug
100 mg immediate-release tablet, dosing q8h
Trazodone HClDrug
Also called Oleptro
300 mg extended-release caplet, single dose

Study groups in NCT00839072
Study group	Role	What they receive
Trazodone Contramid OAD	Experimental	Not described Receives: Drug: Trazodone HCl
Desyrel	Active comparator	Not described Receives: Drug: Trazodone HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence Based on Cmax
Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)
Measured: 72 hours post-dose
Bioequivalence Based on AUCT
AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration
Measured: 72 hours post-dose
Bioequivalence Based on AUC∞
AUC∞ = Area under the concentration-time curve extrapolated to infinity
Measured: 72 hours post-dose

Secondary outcomes (3)

Time of Maximum Measured Plasma Concentration (Tmax)
Measured: 72 hours post-dose
Apparent Terminal Elimination Half-Life [T½el]
The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.
Measured: 72 hours post-dose
Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Mar 2009

First posted9 Feb 2009 (estimated)
Study startFeb 2009
Primary completionFeb 2009
Study completionMar 2009

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 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839072
Sponsor's protocol ID: 04ACL1-011
Other IDs: TAN-P8-681
Status last verified: Apr 2012
First submitted: 6 Feb 2009
Last updated: 27 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Crossover Comparative Bioavailability Study of Trazodone Contramid(r) OAD 300 mg Extended-release Caplets and Desyrel(r) 100 mg Immediate-release Tablets in Healthy Adult Volunteers Under Fasting Conditions
ClinicalTrials.gov ID: NCT00839072
Acronym / sponsor ID: 04ACL1-011
Conditions: Healthy
Keywords: bioavailability, pharmacokinetics, healthy, crossover, trazodone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Collaborators: Algorithme Pharma Inc
Study start: Feb 2009
Primary completion: Feb 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 9 Feb 2009 (estimated)
Results: Posted 16 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Trazodone Contramid OAD	Experimental	Drug: Trazodone HCl
Desyrel	Active comparator	Drug: Trazodone HCl

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Availability for entire study period and willingness to adhere to protocol requirements as evidenced by signed informed consent
Male or female volunteer, aged between 18 and 45 years inclusively
BMI ≥20 and <30 kg/m2
Minimum body weight: 60 kg
Clinical laboratory values within normal range, or without clinical significance

Key exclusion criteria (18 listed)

Significant history of hypersensitivity to trazodone or any related products, or severe hypersensitivity reactions to any drugs
Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric disease
Use of MAO inhibitors within 28 days of day 1 of the study

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
Trazodone HCl100 mg immediate-release tablet, dosing q8h	Drug	Desyrel
Trazodone HClAlso: Oleptro300 mg extended-release caplet, single dose	Drug	Trazodone Contramid OAD

Primary outcome

Bioequivalence Based on Cmax
Time frame: 72 hours post-dose
Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)
Bioequivalence Based on AUCT
Time frame: 72 hours post-dose
AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration
Bioequivalence Based on AUC∞
Time frame: 72 hours post-dose
AUC∞ = Area under the concentration-time curve extrapolated to infinity

3 secondary outcomes

Time of Maximum Measured Plasma Concentration (Tmax)
Time frame: 72 hours post-dose
Apparent Terminal Elimination Half-Life [T½el]
Time frame: 72 hours post-dose
Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]
Time frame: 24 hours

Results and safety

Results posted to the registry on 16 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Trazodone Contramid® OAD) First	12	10
Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First	12	11

Primary outcome: Bioequivalence Based on Cmax

Time frame: 72 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Trazodone Contramid® OAD n = 20	Desyrel® n = 20
Value	1060.8 (366.6)	1743.3 (470.1)

Trazodone Contramid® OAD vs Desyrel®: Ratio of the mean: 59.66 (90% CI 50.99 to 69.81)

Population analysed: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.

Primary outcome: Bioequivalence Based on AUCT

Time frame: 72 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Trazodone Contramid® OAD n = 20	Desyrel® n = 20
Value	29180.6 (10557.1)	36002.4 (9636.4)

Trazodone Contramid® OAD vs Desyrel®: Ratio of the mean: 78.55 (90% CI 69.70 to 88.51)

Population analysed: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.

Primary outcome: Bioequivalence Based on AUC∞

Time frame: 72 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Trazodone Contramid® OAD n = 20	Desyrel® n = 20
Value	30913.7 (11904.8)	37273.4 (10738.5)

Trazodone Contramid® OAD vs Desyrel®: Ratio of the mean: 80.05 (90% CI 70.67 to 90.68)

Population analysed: The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trazodone Contramid® OAD	0 of 23 (0%)	20 of 23 (87%)	Not reported
Desyrel®	0 of 22 (0%)	21 of 22 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Eric Sicard, MD principal investigator

Algorithme Pharma Inc

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 Trazodone HCl in people with Healthy, run by Labopharm 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 7 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 27 Apr 2012. 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?

Yes. Results are posted in the registry (first posted 16 Aug 2010). 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?

Bioequivalence Based on Cmax (time frame: 72 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00839072.

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 27 Apr 2012.