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

NCT ID: NCT05108051

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2021-03-17

Brief 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.

Conditions

Drug-drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ZSP1273

Intervention Type: DRUG

ZSP1273 tablets 600mg administered orally once daily

Oseltamivir

Intervention Type: DRUG

Oseltamivir 75mg administered orally twice daily

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.

Group Type: EXPERIMENTAL

ZSP1273

Intervention Type: DRUG

ZSP1273 tablets 600mg administered orally once daily

Oseltamivir

Intervention Type: DRUG

Oseltamivir 75mg administered orally twice daily

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.

Group Type: EXPERIMENTAL

ZSP1273

Intervention Type: DRUG

ZSP1273 tablets 600mg administered orally once daily

Oseltamivir

Intervention Type: DRUG

Oseltamivir 75mg administered orally twice daily

Interventions

ZSP1273

ZSP1273 tablets 600mg administered orally once daily

Intervention Type: DRUG

Oseltamivir

Oseltamivir 75mg administered orally twice daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

References

Pang Y, Li H, Chen X, Cao Y, Jiang H, Huang J, Liu Y. A phase I, single-center, randomized, open-label, three-period crossover study to evaluate the drug-drug interaction between ZSP1273 and oseltamivir in healthy Chinese subjects. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0172924. doi: 10.1128/aac.01729-24. Epub 2025 Feb 24.

Reference Type: DERIVED

PMID: 39992105 (View on PubMed)

Other Identifiers

ZSP1273-20-05

Identifier Type: -

Identifier Source: org_study_id