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A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

NCT05789342 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-11-14

No results posted yet for this study

Summary

This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.

Conditions

  • Healthy Volunteers

Interventions

DRUG

GP681

GP681, tablet, oral

DRUG

Rosuvastatin

Rosuvastatin, tablet, oral

DRUG

Digoxin

Digoxin, tablet, oral

DRUG

Itraconazole

Itraconazole, capsule, oral

DRUG

Oseltamivir

Oseltamivir, capsule, oral

Sponsors & Collaborators

  • Jiangxi Qingfeng Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jintong Li · China-Japan Friendship Hospital

  • Gang Cui · China-Japan Friendship Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-09-11
Completion
2023-10-31

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 NCT05789342 on ClinicalTrials.gov