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Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects

NCT03302182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-03-21

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

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 .

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-23
Primary Completion
2017-11-04
Completion
2017-12-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302182 on ClinicalTrials.gov