PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese

NCT02785601 | Completed Phase 1

• 1 other identifier: Zhaoke-201603-Tra-Trial I
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Area Under Curve (AUC)

  To observe area under curve characteristics of trazodone hydrochloride prolonged-release tablets in single or multiple dose groups

  pre-dose, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration

• Area Under Curve (AUC)

  To observe area under curve characteristics of trazodone hydrochloride prolonged-release tablets in fasting or high-fat diet groups

  pre-dose, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration

Study Arms (4)

I-1

EXPERIMENTAL

This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg;

Drug: Trazodone Hydrochloride prolonged-release tablets

I-2

EXPERIMENTAL

This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times)

Drug: Trazodone Hydrochloride prolonged-release tablets

I-3

EXPERIMENTAL

This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg;

Drug: Trazodone Hydrochloride prolonged-release tablets

I-4

EXPERIMENTAL

This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg;

Drug: Trazodone Hydrochloride prolonged-release tablets

Interventions

Trazodone Hydrochloride prolonged-release tablets DRUG

strength 75mg, 150 mg. Oral administration with 200ml water

I-1; I-2; I-3; I-4

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)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Andrea On Yan Luk

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

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)