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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug-drug Interaction
• Intervention / Treatment: Drug: ZSP1273; Drug: Oseltamivir

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sequence 1; Period 1: study of ZSP1273's pharmacokinetics at steady state； Period 2: study of Oseltamivir's pharmacokineticsat at steady state； Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state.	Drug: ZSP1273; ZSP1273 tablets 600mg administered orally once daily; Drug: Oseltamivir; Oseltamivir 75mg administered orally twice daily
Experimental: sequence 2; Period 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state.	Drug: ZSP1273; ZSP1273 tablets 600mg administered orally once daily; Drug: Oseltamivir; Oseltamivir 75mg administered orally twice daily
Experimental: sequence 3; Period 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state.	Drug: ZSP1273; ZSP1273 tablets 600mg administered orally once daily; Drug: Oseltamivir; Oseltamivir 75mg administered orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma pharmacokinetics	Tmax	pre-dose and up to 72hours post-dose
Plasma pharmacokinetics	t1/2	pre-dose and up to 72hours post-dose
Plasma pharmacokinetics	Cmax	pre-dose and up to 72hours post-dose
Plasma pharmacokinetics	AUC0-∞	pre-dose and up to 72hours post-dose
Plasma pharmacokinetics	CL/F	pre-dose and up to 72hours post-dose
Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)	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.	up to 37days

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): March 17, 2021
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: ZSP1273-20-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No