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

NCT02785614 | Completed Phase 1

• 1 other identifier: Zhaoke-201603-Tra-Trial II
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  To observe area under curve characteristics of Trazodone in single or multiple dose groups

  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

Study Arms (2)

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.

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.

Drug: trazodone hydrochloride prolonged-release tablet; Drug: trazodone hydrochloride tablet

Interventions

trazodone hydrochloride prolonged-release tablet DRUG

150 mg, oral administration, 1 per day

II-1; II-2

trazodone hydrochloride tablet DRUG

50mg, oral administration 3 times per day

II-1; II-2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Phase I Clinical Trial Centre, Chinese University of Hong Kong

Hong Kong, Sha Tin New Territories, 000000, Hong Kong

Location

MeSH Terms

Conditions

Depression

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 4, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

HK (1)