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Completed

NCT Number: NCT05108051

Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir

To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.

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Key information

Conditions

Drug-drug Interaction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and female subjects between 18-45 years (Both inclusive);
  • Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18~26 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
  • Subjects (including partners) are willing to voluntarily use effective contraception from screening to 3 months after the last study drug administration.

Exclusion criteria

  • Known history of allergic constitution (multiple drugs especially with ZSP1273 or oseltamivir and its preparation of the main ingredient allergy, food allergy);
  • Subjects who donated blood or bleeding profusely(> 450 mL)in the 3 months preceding study screening;
  • History or presence of any disease or condition known to increase the risk of bleeding, eg.hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc;
  • Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening;
  • Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of drug metabolic enzymes ，is intended to be taken in combination 28 days prior to screening or during the study period；
  • Participated in another clinical research study or received any investigational products within 3 months prior to dosing;
  • Presence of clinically significant abnormalities in ECG , QTcB>450ms in males,or QTcB>470ms in females;
  • Any of the following diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases) that are clinically significant in clinical laboratory examination or other clinical findings within 6 months prior to screening;
  • Breast-feeding women or those with positive pregnancy test results;
  • Subjects who should not be included in the study in the opinion of the Investigator.

Treatment and study plan

ZSP1273

Drug

ZSP1273 tablets 600mg administered orally once daily

oseltamivir

Drug

Oseltamivir 75mg administered orally twice daily

Primary outcomes

  1. Plasma pharmacokinetics

    Time frame: pre-dose and up to 72hours post-dose

    Tmax

  2. Plasma pharmacokinetics

    Time frame: pre-dose and up to 72hours post-dose

    t1/2

  3. Plasma pharmacokinetics

    Time frame: pre-dose and up to 72hours post-dose

    Cmax

  4. Plasma pharmacokinetics

    Time frame: pre-dose and up to 72hours post-dose

    AUC0-∞

  5. Plasma pharmacokinetics

    Time frame: pre-dose and up to 72hours post-dose

    CL/F

  6. Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)

    Time frame: up to 37days

    TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Phase 1, Open-Label, Three-Period, Single-center Study to Assess the Pharmacokinetic Interactions Between ZSP1273 and Oseltamivir in Healthy Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2021
Registry last updated
Nov 4, 2021

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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