HealthyPhase 1NCT05136521
Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions
A Phase 1 study testing Trazodone HCl - new polymer and Trazodone HCl - Contramid® in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions. 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 - new polymer and Trazodone HCl - Contramid®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Feb 2020to 19 Jul 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men and women, 18-45 years old inclusive
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
- Contraception and fertility : men and women of child-bearing potential and with an active sexual life must be using at least one of the following reliable methods of contraception throughout the study:
Show all 12Show fewer
- Hormonal oral, implantable, intrauterine device [IUD], transdermal, or injectable contraceptives for at least 2 months before the screening visit (women only)
- A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit (women only)
- A male sexual partner who agrees to use a male condom with spermicide (women only)
- A vasectomised partner (women only)
- A male condom with spermicide (men only)
- A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted
Who cannot join
- Electrocardiogram (ECG): clinically significant abnormalities at 12-lead ECG in supine position
- QTc: QTcF>430 msec for men and QTcF>450 msec for women at screening
- Cardiac disorders: history of risk factors for torsade de pointes, such as heart failure, significant cardiac arrhythmias, significant cardiac conduction abnormalities, family history of long QT syndrome, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
Show all 15Show fewer
- Diseases: history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
- Medications: medications, including over the counter (OTC) medications and herbal remedies and in particular concomitant intake of potentially hepatotoxic drugs or hepatic/gastric enzyme inducers (i.e. phenobarbital, phenytoin, carbamazepine, chlorzoxazone and rifampicin) for 2 weeks before the start of the study. Hormonal contraceptives for women will be allowed
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval will be calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- Blood donation: blood donations for 3 months before this study
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for women and >2 drinks/day for men, defined according to USDA Dietary Guidelines 2015-2020 (18)], caffeine (>5 cups coffee/tea/day) or tobacco (> or equal 6 cigarettes/day) abuse;
- Drug test: positive drug test at screening or day -1
- Alcohol breath test: positive alcohol breath test at day -1
- Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- Pregnancy: pregnant or lactating women; positive or missing pregnancy test at screening or day -1
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 Phone: Fax: +41.91.63.00.511 Email:
Arzo, CH-6864
About this study
Official title: A Randomized, Two-way Cross-over Comparative Bioavailability Study of 300 mg Trazodone Hydrochloride Containing New Polymer vs. 300 mg Trazodone Hydrochloride Containing Contramid® Prolonged-release Tablets Under Fasting Conditions
This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.
Read the detailed description
A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.
To investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.
- Conditions
- Healthy
- Being tested
- Trazodone HCl - new polymer, Trazodone HCl - Contramid®
- Keywords
- Bioavailability, Cross over, trazodone hydrochloride (HCl) (new polymer), Trittico®, 300 mg trazodone HCl, Bioequivalence, prolonged-release tablets, Contramid®,
- Medical subject headings
- Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trazodone HCl - new polymerDrug
A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.
Trazodone HCl - Contramid®Drug
Also called Trittico®
A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.
| Study group | Role | What they receive |
|---|---|---|
| 300 mg trazodone hydrochloride (HCl) prolonged-release tablets (new polymer) | Experimental | Subjects treated with 300 mg trazodone HCl prolonged-release tablets containing a new polymer, Receives: Drug: Trazodone HCl - new polymer |
| Trittico®, 300 mg trazodone HCl prolonged-release tablets (Contramid®) | Active comparator | Subjects treated with Trittico®, 300 mg trazodone HCl prolonged-release tablets containing Contramid® Receives: Drug: Trazodone HCl - Contramid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
AUC(0-t)
AUC(0-t) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
AUC(0-∞)
AUC(0-∞) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
Secondary outcomes (6)
Treatment emergent adverse events (TEAEs)
All AEs occurring or worsening after the first dose of IMP. Adverse events (AEs) will be coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: Trough study completion, an average of five months
Residual area
Residual area of plasma trazodone (free base). Extrapolated area calculated as (AUC(0-∞) - AUC(0-t))/ AUC(0-∞)
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
tmax
Time to achieve Cmax of plasma trazodone (free base)
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
tlag
Lag-time observed from the dosing time point prior to that of the first measurable plasma concentration (≥ LLOQ) (tlag ≥ 0) of plasma trazodone (free base)
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
λz
λz is apparent terminal elimination rate constant, calculated, if feasible, by log-linear regression using at least 3 points of plasma trazodone (free base)
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
t1/2
Apparent terminal elimination half-life, calculated, if feasible, as ln2/λz,
Measured: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start17 Feb 2020
- Primary completion19 Jul 2020
- Study completion19 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is single dose, open-label, randomised, two-period, two-sequence, cross-over, bioavailability and bioequivalence study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136521
- Sponsor's protocol ID
- 039(C/a)WO19390
- Other IDs
- CRO-PK-19-340
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-way Cross-over Comparative Bioavailability Study of 300 mg Trazodone Hydrochloride Containing New Polymer vs. 300 mg Trazodone Hydrochloride Containing Contramid® Prolonged-release Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05136521
- Acronym / sponsor ID
- 039(C/a)WO19390
- Conditions
- Healthy
- Keywords
- Bioavailability, Cross over, trazodone hydrochloride (HCl) (new polymer), Trittico®, 300 mg trazodone HCl, Bioequivalence, prolonged-release tablets, Contramid®,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- 19 Jul 2020 (actual)
- First posted
- 29 Nov 2021 (actual)
- 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.
This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.
Detailed description
A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.
To investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is single dose, open-label, randomised, two-period, two-sequence, cross-over, bioavailability and bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| 300 mg trazodone hydrochloride (HCl) prolonged-release tablets (new polymer) | Experimental | Drug: Trazodone HCl - new polymerSubjects treated with 300 mg trazodone HCl prolonged-release tablets containing a new polymer, |
| Trittico®, 300 mg trazodone HCl prolonged-release tablets (Contramid®) | Active comparator | Drug: Trazodone HCl - Contramid®Subjects treated with Trittico®, 300 mg trazodone HCl prolonged-release tablets containing Contramid® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men and women, 18-45 years old inclusive
- Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
Key exclusion criteria (15 listed)
- Electrocardiogram (ECG): clinically significant abnormalities at 12-lead ECG in supine position
- QTc: QTcF>430 msec for men and QTcF>450 msec for women at screening
- Cardiac disorders: history of risk factors for torsade de pointes, such as heart failure, significant cardiac arrhythmias, significant cardiac conduction abnormalities, family history of long QT syndrome, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
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 HCl - new polymerA single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting. | Drug | 300 mg trazodone hydrochloride (HCl) prolonged-release tablets (new polymer) |
| Trazodone HCl - Contramid®Also: Trittico®A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting. | Drug | Trittico®, 300 mg trazodone HCl prolonged-release tablets (Contramid®) |
Primary outcome
Cmax
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
Cmax of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
AUC(0-t)
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
AUC(0-t) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
AUC(0-∞)
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
AUC(0-∞) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).
6 secondary outcomes
Treatment emergent adverse events (TEAEs)
Time frame: Trough study completion, an average of five months
Residual area
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
tmax
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
tlag
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
λz
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
t1/2
Time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose
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 29 Nov 2021.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
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 - new polymer and Trazodone HCl - Contramid® in people with Healthy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
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 12 inclusion and 15 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 29 Nov 2021. 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 Switzerland. 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?
Cmax (time frame: At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 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?
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 29 Nov 2021.