NCT02785614

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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). 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

Interventions

Type	Name	Description
DRUG	trazodone hydrochloride prolonged-release tablet	150 mg, oral administration, 1 per day
DRUG	trazodone hydrochloride tablet	50mg, oral administration 3 times per day

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-11-30
• Completion: 2018-01-04
• First posted: 2016-05-30
• Last updated: 2018-09-05

Locations

1 site across 1 country: Hong Kong