DepressionPhase 1NCT02785614

PK Study of Multi-dose Trazodone Hydrochloride Prolonged-released Tablets in Healthy Chinese

A Phase 1 study testing trazodone hydrochloride prolonged-release tablet and trazodone hydrochloride tablet in people with Depression, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.

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

The main objective is to evaluate the pharmacokinetics comparative studies in a single dose, multiple dose Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: trazodone hydrochloride prolonged-release tablet and trazodone hydrochloride tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteHong Kong
Study dates: 1 May 2017to 4 Jan 2018
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 19 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Weight: all the subjects should be≥50 kg, BMI within 19~24 kg/m2
Blood pressure: SBP 90-140mmHg，DBP 50-90 mmHg；
All the subjects should understand this trial well and sign the inform consent form before participating this study;
Subjects should be able to communicate with investigators well and complete this study in accordance with protocol.

Who cannot join

The baseline value of safety evaluation index is considered to be abnormal with clinical significance by investigators before participating the trial.
A positive hepatitis B surface antigen result；
A positive hepatitis C surface antigen result；
A positive test for HIV antibody and syphilis testing；
Any of the abnormalities of ECGs examination occurs in screening period or the first day of administration:
With the history of using any drug which will inhibit or induce liver to metabolize drug within 1 month before the study initiation;

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With the history of administrating any drugs (prescription medicine, over-the-counter drug and Chinese herbal medicine) within 2 week before the study initiation;
Past history of heart disease, cardiac failure, myocardial infarction, angina, unknown cause of arrhythmia, point swinging pattern of ventricular tachycardia, ventricular tachycardia, long QT syndrome or long QT syndrome and family history (with genetic proof or there were any close relatives died because of heart disease);
History of thyroid disease or past history of thyroid surgery;
History of immune system disease (such as thymus disease)；
With surgery history within 6 months before this study initiation；
History of severe digestive disease (such as gallbladder disease with significant clinical significance, jaundice or susceptive jaundice, hepatocellular adenoma, hepatic cavernous hemangioma and the other liver diseases)；
With history of gastrointestinal, liver and renal disease (no matter it has been cured or not) which will affect drug absorption and metabolism within 6 months before this study initiating
History of any serve cardiocerebral vascular system, respiratory system, metabolic system and nervous system diseases;
History of hematological system diseases, such as coagulation disorders；
History of tumor；
Subjects with hypokalemia and hypocalcemia (according to the lower limit value of the laboratory reference ranges；
Life style:
History of alcohol addicted within 6 months before the study
Smoking >1 cigarettes a day in the last 3 months prior to this study;
History of drug abuse and taking drugs (such as marihuana, cocaine, opium, benzodizepines, amphetamines, barbiturates, tricyclic antidepressant).
History of consumption of excessive tea, coffee and/or caffeinated beverage (more than 8 cups/day) within the period of 2 days before the administration and 8 days after administration.
History of consumption of grapefruit juice within the period of 2 days before and 8 days after administration.
Others：
Subjects who reject to take effective contraceptive measures within the time period after inclusion to 3 months after administration;
Subjects with allergic constitution, including those who are allergic to the excipient (microcrystalline cellulose, lactose, aerosil, sodium carboxymethyl starch, magnesium stearate) of this product;
History of participating any clinical trial within 3 months before this study, or participating the other clinical trial within the time period of inclusion to one month after the last time visit(after the last time administration);
History of blood donation within 3 months prior to this study, or within the time period of inclusion to one month after the last time visit (after the last time administration);
Subjects who have food allergy or have any special diet requirements, or who cannot follow the standard diet;
Subjects who, in the opinion of the investigator, should not participate in the study；
The female subjects are not eligible for inclusion in this study if she meet any of the following criteria above and below:
With the history of consumption of oral contraceptive within one month prior to this study；
History of long-acting estrogen or progesterone injection or implant within 6 months prior to this study;
The bearing-age female subjects who have not taken appropriate contraceptives within 2 weeks prior to this study;
The bearing-age female subjects and their spouse are not willing to take the following contraceptives measure, condom, copper intrauterine device within 3 months after inclusion;
Subjects who are in gestation period and lactation period;
Subjects with positive hCG test;
Single menstrual more than 80ml.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Phase I Clinical Trial Centre, Chinese University of Hong Kong
Hong Kong, Sha Tin New Territories, 000000

Other trials in Hong Kong

About this study

Official title: Pharmacokinetics Study of Trazodone Hydrochloride Prolonged-Released Tablets in Chinese Healthy Volunteers

The main objective is to evaluate the pharmacokinetics comparative studies in a single dose, multiple dose

Read the detailed description

Trial II Multiple dose, the highest specification (150mg) pharmacokinetic study of Trazodone Hydrochloride Prolonged Release Tablets; 12 patients (males and females, half and half).

2-period, 2 cross (2x2) crossover design was used. screened 12 subjects (males and females) were randomly divided into two groups (II-1、II-2), each 3 males and 3 females, give the following two different crossover treatments: trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days in T group, trazodone hydrochloride tablets 50mg for 3 times per day for 7 days in R group. Wash-out period is 14 days.

Trial II. 2X2 design Group Period 1 Period 2 II -1 R T II -2 T R T group: the subjects will be provided trazodone hydrochloride prolonged-release tablet 150mg at about8:00am each day. Sampling site will be conducted in day 1, 5, 6, 7 before administration in this period, blood sampling will be conducted in 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0h after administration on day 7.

R group: The subjects will receive 50mg trazodone hydrochloride tablet 50mg for 3 times after receiving standard light breakfast at 6:00am, standard meal at 14:00 and 22:00. Blood sampling will be conducted on day 1, 5, 6, 7 before first administration in this period, blood sampling will be conducted at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0 (before the second time administration), 8.5, 9.0, 9.5, 10.0, 11.0, 12.0, 14.0, 16.0 (before the third time administration), 16.5, 17.0, 17.5, 18.0, 19.0, 20.0, 22.0, 24.0, 36.0, 48.0, 72.0h after administration on day 7.

5.0 mL venous blood from forearm venous blood was took through venous indwelling needle and transfer into the heparin tube. After plasma separation it stored in low temperature in a refrigerator.

Conditions: Depression
Being tested: trazodone hydrochloride prolonged-release tablet, trazodone hydrochloride tablet
Medical subject headings: Depression

What participants receive

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

trazodone hydrochloride prolonged-release tabletDrug
150 mg, oral administration, 1 per day
trazodone hydrochloride tabletDrug
50mg, oral administration 3 times per day

Study groups in NCT02785614
Study group	Role	What they receive
II-1	Experimental	This is 2-period, 2 cross (2x2) crossover design was used. each 3 males and 3 females, give the following two different crossover treatments in the following sequence: R: trazodone hydrochloride tablets 50mg for 3 times per day for 7 days T: trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days. Wash-out period is 14 days. Receives: Drug: trazodone hydrochloride prolonged-release tablet; Drug: trazodone hydrochloride tablet
II-2	Experimental	This is 2-period, 2 cross (2x2) crossover design was used. each 3 males and 3 females, give the following two different crossover treatments in the following sequence: T: trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days R: trazodone hydrochloride tablets 50mg for 3 times per day for 7 days. Wash-out period is 14 days. Receives: Drug: trazodone hydrochloride prolonged-release tablet; Drug: trazodone hydrochloride tablet

What is being measured

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

Area Under Curve (AUC)
To observe area under curve characteristics of Trazodone in single or multiple dose groups
Measured: day 1, 5, 6, 7 before administration and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration on day 7

Timeline

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

1 May 20174 Jan 2018

First posted30 May 2016 (estimated)
Study start1 May 2017
Primary completion30 Nov 2017
Study completion4 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02785614
Sponsor's protocol ID: Zhaoke-201603-Tra-Trial II
Status last verified: Sep 2018
First submitted: 24 May 2016
Last updated: 5 Sep 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics Study of Trazodone Hydrochloride Prolonged-Released Tablets in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT02785614
Acronym / sponsor ID: Zhaoke-201603-Tra-Trial II
Conditions: Depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
Study start: 1 May 2017 (actual)
Primary completion: 30 Nov 2017 (actual)
Study completion: 4 Jan 2018 (actual)
First posted: 30 May 2016 (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 main objective is to evaluate the pharmacokinetics comparative studies in a single dose, multiple dose

Detailed description

Trial II Multiple dose, the highest specification (150mg) pharmacokinetic study of Trazodone Hydrochloride Prolonged Release Tablets; 12 patients (males and females, half and half).

5.0 mL venous blood from forearm venous blood was took through venous indwelling needle and transfer into the heparin tube. After plasma separation it stored in low temperature in a refrigerator.

Study design

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

Arm	Type	Receives
II-1	Experimental	Drug: trazodone hydrochloride prolonged-release tablet, Drug: trazodone hydrochloride tabletThis is 2-period, 2 cross (2x2) crossover design was used. each 3 males and 3 females, give the following two different crossover treatments in the following sequence: R: trazodone hydrochloride tablets 50mg for 3 times per day for 7 days T: trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days. Wash-out period is 14 days.
II-2	Experimental	Drug: trazodone hydrochloride prolonged-release tablet, Drug: trazodone hydrochloride tabletThis is 2-period, 2 cross (2x2) crossover design was used. each 3 males and 3 females, give the following two different crossover treatments in the following sequence: T: trazodone hydrochloride prolonged-release tablets 150 mg per day for 7 days R: trazodone hydrochloride tablets 50mg for 3 times per day for 7 days. Wash-out period is 14 days.

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Weight: all the subjects should be≥50 kg, BMI within 19~24 kg/m2
Blood pressure: SBP 90-140mmHg，DBP 50-90 mmHg；
All the subjects should understand this trial well and sign the inform consent form before participating this study;
Subjects should be able to communicate with investigators well and complete this study in accordance with protocol.

Key exclusion criteria (38 listed)

The baseline value of safety evaluation index is considered to be abnormal with clinical significance by investigators before participating the trial.
A positive hepatitis B surface antigen result；
A positive hepatitis C surface antigen result；
A positive test for HIV antibody and syphilis testing；
Any of the abnormalities of ECGs examination occurs in screening period or the first day of administration:

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 hydrochloride prolonged-release tablet150 mg, oral administration, 1 per day	Drug	II-1, II-2
trazodone hydrochloride tablet50mg, oral administration 3 times per day	Drug	II-1, II-2

Primary outcome

Area Under Curve (AUC)
Time frame: day 1, 5, 6, 7 before administration and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration on day 7
To observe area under curve characteristics of Trazodone in single or multiple dose groups

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 5 Sep 2018.

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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.

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 hydrochloride prolonged-release tablet and trazodone hydrochloride tablet in people with Depression, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.

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 38 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 5 Sep 2018. 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 Hong Kong. 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?

Area Under Curve (AUC) (time frame: day 1, 5, 6, 7 before administration and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration on day 7). 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 NCT02785614.

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 5 Sep 2018.