MedTrace Logo

A Pilot Bioequivalence Study of Pomalidomide

NCT03424928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-02-07

No results posted yet for this study

Summary

Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.

Conditions

  • Bioequivalence

Interventions

DRUG

Pomalidomide 4 MG Oral Capsule

per os,capsule,4mg,1 capsule per period

DRUG

Pomalidomide 4 MG Oral Capsule-Pomalyst

per os,capsule,4mg,1 capsule per period

Sponsors & Collaborators

  • Second Hospital of Shanxi Medical University

    collaborator OTHER

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ruigang Hou, Bachelor · Second Hospital of Shanxi Medical University

  • Linhua Linhua, PhD · Second Hospital of Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2018-01-29
Completion
2018-02-06

Countries

  • China

Study Locations

More Related Trials

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 NCT03424928 on ClinicalTrials.gov