NCT03847246

Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers

A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study to Assess the Bioequivalence of Entecavir Tablets 1.0 mg With Baraclude® 1.0 mg in Healthy Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions.

Detailed description

This is a single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation Entecavir Tablets 1.0 mg with reference formulation Entecavir Tablets (Baraclude®) 1.0 mg in healthy adult subjects under fasting conditions. Each subject will be randomized to one of two treatment sequences (TR, RT) according to a randomization schedule prepared prior to the start of the study. There will be a 21-day washout between each single dose administration. Subjects in each group will be dosed on the same day for Day 1 of Period 1, and all subjects in each group will be crossed over to the alternate formulation and will be dosed on the same day for Day 22 of Period 2.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Baraclude® tablets,1.0 mg	oral,once,under fasting condition
DRUG	Entecavir tablets,1.0 mg	oral,once,under fasting condition

Timeline

• Start date: 2018-12-04
• Primary completion: 2018-12-28
• Completion: 2018-12-28
• First posted: 2019-02-20
• Last updated: 2019-02-20

Locations

1 site across 1 country: China