NCT03302182

Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

An Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.

Detailed description

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Ritonavir for cycle1 and NORVIR for cycle 2	During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
DRUG	NORVIR for cycle 1 and Ritonavir for cycle 2	During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .

Timeline

• Start date: 2017-09-23
• Primary completion: 2017-11-04
• Completion: 2017-12-04
• First posted: 2017-10-05
• Last updated: 2018-03-21

Locations

1 site across 1 country: China