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Completed

NCT Number: NCT05954624

Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid

The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Guangzhou University of Chinese medicine

Guangzhou, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
  • Ability to understand and willingness to sign a written informed consent form;
  • Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion criteria

  • Participants with a history of hypersensitivity to study drug(ZSP1273,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;
  • Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to screening;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening,or who cannot stop using any tobacco products during the study period;
  • Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
  • Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
  • Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
  • Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • History of dysphagia or any gastrointestinal disorder that affect absorption

Treatment and study plan

Digoxin

Drug

oral

Rosuvastatin

Drug

oral

ZSP1273

Drug

oral

Itraconazole

Drug

oral

Probenecid

Drug

oral

Primary outcomes

  1. Pharmacokinetic - Cmax

    Time frame: 0-168 hours

    Maximum observed plasma concentration

  2. Pharmacokinetic -Area under the curve(AUC)

    Time frame: 0-168 hours

    Area under the curve

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Day1 to Day30

    The safety and tolerability of ZSP1273 alone and in combination with Itraconazole, rosuvastatin, Probenecid and digoxin will be examined.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
Jan 29, 2024

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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