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Completed

NCT Number: NCT04080609

DDI Study Between Dorzagliatin and Rifampicin

The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.

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Key information

Conditions

Drug Interaction

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Central Hospital of Xuhui District

Shanghai, Shanghai Municipality, 201203, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
  • BMI within 19～26 kg/m2

Exclusion criteria

  • History or disease status that may impact the ADME of the study
  • Use of any drugs, OTCs, or hebal within 4 weeks of screening
  • Drug abuse
  • Blood donation

Treatment and study plan

Dorzagliatin

Drug

GKA currently under clinical development

Primary outcomes

  1. Cmax

    Time frame: up to 96 hours

    Peak plasma concentration

  2. AUClast

    Time frame: up to 96 hours

    Area under the plasma concentration curve

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Registry information

Official study title

A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2019
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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