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

Drug-drug Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108051
• Other study ID #: ZSP1273-20-05
• Status: Completed
• Phase: Phase 1
• Start date: November 19, 2020
• Est. completion date: March 17, 2021

Study information

• Verified date: October 2021
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug-drug Interaction

Intervention

Drug:
• ZSP1273
ZSP1273 tablets 600mg administered orally once daily
• Oseltamivir
Oseltamivir 75mg administered orally twice daily

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetics	Tmax	pre-dose and up to 72hours post-dose
Primary	Plasma pharmacokinetics	t1/2	pre-dose and up to 72hours post-dose
Primary	Plasma pharmacokinetics	Cmax	pre-dose and up to 72hours post-dose
Primary	Plasma pharmacokinetics	AUC0-8	pre-dose and up to 72hours post-dose
Primary	Plasma pharmacokinetics	CL/F	pre-dose and up to 72hours post-dose
Primary	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