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Pharmacokinetics Study of XG005 Capsule

NCT04499209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-08-18

No results posted yet for this study

Summary

This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.

Conditions

Interventions

DRUG

XG005

XG005 Capsule

DRUG

Combination of Naproxen and Pregabalin

Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica

DRUG

Placebos

Placebo Capsule

Sponsors & Collaborators

  • Xgene Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2018-01-18
Completion
2018-03-19

Countries

  • Australia

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 NCT04499209 on ClinicalTrials.gov