HealthyPhase 1NCT01121900

A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)

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

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 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: 26 participants
Where: No sites listed yet
Study dates: Jun 2008to Jul 2008
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects 18 to < 56 years of age.
Body mass within 10% of the ideal mass in relation to height and age, according to Body Mass Index.
Body mass not less than 53 kg.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
Normal 12-lead electrocardiogram (ECG) and vital signs, or abnormalities, which the investigator did not consider a disqualification for participation in the study.
Willingness to undergo a pre- and post-study physical examination and laboratory investigations.

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Ability to comprehend and willingness to sign both statements of informed consent (for screening and period-related procedures).
Non-smoker or past smoker who stopped the use of any form of tobacco, including snuff or similar products, at least 3 months before entering the study.
For females, the following conditions had to be met:
Had been surgically sterilized or undergone a hysterectomy, or
Was of childbearing potential, and all of the following conditions were met:
Had a negative pregnancy test at screening. If this test was positive, the subject was to be excluded from the study before receiving study medication. In the rare circumstance that a pregnancy was discovered after the subjects received the study medication, every attempt was to be made to follow such subjects to term.
Had to agree to use an accepted method of contraception (i.e., spermicide and barrier methods or spermicide and non-hormonal intrauterine contraceptive device). The subject had to agree to continue with the same method throughout the study. Hormonal contraceptives were not allowed.
Females not of childbearing potential could also have been included if they had no menstrual period for one year and were considered as post-menopausal.

Who cannot join

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to have limited the validity of consent to participate in the study or to have limited the ability to comply with protocol requirements.
History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not have affected the outcome of the study in the opinion of the investigator. Hormonal contraceptive agents were not allowed.
Participation in another study with an experimental drug, where the last administration (of previous study medication) was within 8 weeks before the first administration of study medication.
Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system.
A major illness during the 3 months before commencement of the screening period.

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History of hypersensitivity to the study medication or any related medication.
History of bronchial asthma.
History of epilepsy.
History of porphyria.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to have influenced the study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of study medication.
Diagnosis of hypotension made during the screening period.
Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
Positive testing for HIV and/or Hepatitis B and/or Hepatitis C.
Positive urine screen for drugs of abuse.
Positive urine screen for tobacco use.
A serum pregnancy test (beta human chorionic gonadotropin [β-HCG]) either positive or not performed or lactation.

About this study

Official title: A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered as a Single Dose) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) Under Fasting Conditions

The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.

Conditions: Healthy
Being tested: Trazodone HCl
Keywords: Healthy subjects

What participants receive

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

Trazodone HClDrug
Also called Oleptro
Dosage form: Extended-release caplets containing 300 mg trazodone HCl
Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours.
Trazodone HClDrug
Dosage form: Immediate-release tablets containing 100 mg trazodone HCl
Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.

Study groups in NCT01121900
Study group	Role	What they receive
Trazodone HCl OAD	Experimental	OAD: Once A Day Receives: Drug: Trazodone HCl
Trazodone HCl (Apotex Corp.)	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 Cmax
Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).
Measured: 68 hours
Bioequivalence Based on AUC(0-tlast)
AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration.
Measured in nanogram x hours per milliliter (ng*h/mL).
Measured: 68 hours
Bioequivalence Based on AUC(0-∞)
AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).
Measured in nanogram x hours per milliliter (ng*h/mL).
Measured: 68 hours

Secondary outcomes (4)

Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]
Measured: 24 hours
Time to Maximum Plasma Concentration (Tmax)
Measured: 68 hours
Apparent Terminal Elimination Rate Constant (λz)
The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.
Measured: 68 hours
Apparent Terminal Half-life (t½.z)
The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.
Measured: 68 hours

Timeline

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

Jun 2008Jul 2008

First posted12 May 2010 (estimated)
Study startJun 2008
Primary completionJul 2008
Study completionJul 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 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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01121900
Sponsor's protocol ID: 04ACL1-010
Status last verified: Apr 2012
First submitted: 10 May 2010
Last updated: 27 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

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?

Official record

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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: A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered as a Single Dose) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) Under Fasting Conditions
ClinicalTrials.gov ID: NCT01121900
Acronym / sponsor ID: 04ACL1-010
Conditions: Healthy
Keywords: Healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 12 May 2010 (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.

Study design

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

Arm	Type	Receives
Trazodone HCl OAD	Experimental	Drug: Trazodone HClOAD: Once A Day
Trazodone HCl (Apotex Corp.)	Active comparator	Drug: Trazodone HCl

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Healthy male and female subjects 18 to < 56 years of age.
Body mass within 10% of the ideal mass in relation to height and age, according to Body Mass Index.
Body mass not less than 53 kg.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
Normal 12-lead electrocardiogram (ECG) and vital signs, or abnormalities, which the investigator did not consider a disqualification for participation in the study.

Key exclusion criteria (19 listed)

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to have limited the validity of consent to participate in the study or to have limited the ability to comply with protocol requirements.
History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not have affected the outcome of the study in the opinion of the investigator. Hormonal contraceptive agents were not allowed.
Participation in another study with an experimental drug, where the last administration (of previous study medication) was within 8 weeks before the first administration of study medication.
Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system.

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 HClAlso: OleptroDosage form: Extended-release caplets containing 300 mg trazodone HCl Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours.	Drug	Trazodone HCl OAD
Trazodone HClDosage form: Immediate-release tablets containing 100 mg trazodone HCl Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.	Drug	Trazodone HCl (Apotex Corp.)

Primary outcome

Bioequivalence Based Cmax
Time frame: 68 hours
Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).
Bioequivalence Based on AUC(0-tlast)
Time frame: 68 hours
AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration. Measured in nanogram x hours per milliliter (ng*h/mL).
Bioequivalence Based on AUC(0-∞)
Time frame: 68 hours
AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞). Measured in nanogram x hours per milliliter (ng*h/mL).

4 secondary outcomes

Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]
Time frame: 24 hours
Time to Maximum Plasma Concentration (Tmax)
Time frame: 68 hours
Apparent Terminal Elimination Rate Constant (λz)
Time frame: 68 hours
Apparent Terminal Half-life (t½.z)
Time frame: 68 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	13	12
Reference (Trazodone IR [Apotex Corp.]) First	13	12

Primary outcome: Bioequivalence Based Cmax

Time frame: 68 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Trazodone Contramid® OAD n = 23	Trazodone IR (Apotex Corp.) n = 23
Value	1230.7 (499.1)	2947.7 (734.7)

Trazodone Contramid® OAD vs Trazodone IR (Apotex Corp.): Mean ratio: 39.8 (90% CI 34.4 to 46.0)

Population analysed: The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.

Primary outcome: Bioequivalence Based on AUC(0-tlast)

Time frame: 68 hours. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Trazodone Contramid® OAD n = 23	Trazodone IR (Apotex Corp.) n = 23
Value	28138.4 (8400.0)	34272.4 (9792.8)

Trazodone Contramid® OAD vs Trazodone IR (Apotex Corp.): Mean ratio: 80.9 (90% CI 74.2 to 88.3)

Population analysed: The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.

Primary outcome: Bioequivalence Based on AUC(0-∞)

Time frame: 68 hours. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Trazodone Contramid® OAD n = 23	Trazodone IR (Apotex Corp.) n = 23
Value	29672.5 (8373.8)	35258.5 (10067.4)

Trazodone Contramid® OAD vs Trazodone IR (Apotex Corp.): Mean ratio: 83.5 (90% CI 76.5 to 91.1)

Population analysed: The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.

4 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 24 (0%)	7 of 24 (29.2%)	Not reported
Trazodone IR (Apotex Corp.)	0 of 25 (0%)	8 of 25 (32%)	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.
Approved LabellingLink 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.

The record lists no contact. Use the official record to reach the sponsor.

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..

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 14 inclusion and 19 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.

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 Cmax (time frame: 68 hours). 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 NCT01121900.

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.