Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants

The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.

Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: ZSP1273 tablet; Drug: zsp1273 granules

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Liu Doctor; Phone Number: 81887233; Email: web@wanmey.com
• Study Contact Backup: Name: Liu Doctor; Phone Number: 020-81887233; Email: web@wanmey.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg 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);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
3. 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;
4. Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
6. 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);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZSP1273 Sequence 1; Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period.	Drug: ZSP1273 tablet; Participants receive ZSP1273 tablet orally.; Drug: zsp1273 granules; Participants receive ZSP1273 granules orally.
Experimental: ZSP1273 Sequence 2; Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period.	Drug: ZSP1273 tablet; Participants receive ZSP1273 tablet orally.; Drug: zsp1273 granules; Participants receive ZSP1273 granules orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.	Day 1 to Day 20
Area under the concentration-time curve from time zero to infinity (AUCinf)	The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.	Day 1 to Day 20
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)	The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.	Day 1 to Day 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	Day 1 to Day 20

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZSP1273-22-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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