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Bioequivalency Study of CM082 Tablet in Healthy Volunteers

NCT04328506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-11-26

No results posted yet for this study

Summary

The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

DRUG

CM082 tablet (test product)

Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals

DRUG

CM082 tablet (reference product)

Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions

Sponsors & Collaborators

  • AnewPharma

    lead INDUSTRY

Principal Investigators

  • zourong ruan · the Second Affiliated Hospital of Zhejiang University Medical College

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
2020-06-01
Primary Completion
2020-07-27
Completion
2020-07-27

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 NCT04328506 on ClinicalTrials.gov