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the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers

NCT02821871 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-07-04

No results posted yet for this study

Summary

All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.

Conditions

Interventions

DRUG

SP2086

DIETARY_SUPPLEMENT

high fat diet

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02821871 on ClinicalTrials.gov