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Trial record 5 of 1420 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT02785614
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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

Condition or disease Intervention/treatment Phase
Depression Drug: trazodone hydrochloride prolonged-release tablet Drug: trazodone hydrochloride tablet Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Trazodone Hydrochloride Prolonged-Released Tablets in Chinese Healthy Volunteers
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : January 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: II-1

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.

Drug: trazodone hydrochloride prolonged-release tablet
150 mg, oral administration, 1 per day

Drug: trazodone hydrochloride tablet
50mg, oral administration 3 times per day

Experimental: II-2

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.

Drug: trazodone hydrochloride prolonged-release tablet
150 mg, oral administration, 1 per day

Drug: trazodone hydrochloride tablet
50mg, oral administration 3 times per day




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785614


Locations
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Hong Kong
Phase I Clinical Trial Centre, Chinese University of Hong Kong
Hong Kong, Sha Tin New Territories, Hong Kong, 000000
Sponsors and Collaborators
Lee's Pharmaceutical Limited

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT02785614     History of Changes
Other Study ID Numbers: Zhaoke-201603-Tra-Trial II
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents