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

NCT ID: NCT06164431

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-23
• Study Completion Date: 2023-12-22

Brief Summary

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.

Conditions

Bioequivalence

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

ZSP1273 tablet

Intervention Type: DRUG

Participants receive ZSP1273 tablet orally.

zsp1273 granules

Intervention Type: DRUG

Participants receive ZSP1273 granules orally.

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.

Group Type: EXPERIMENTAL

ZSP1273 tablet

Intervention Type: DRUG

Participants receive ZSP1273 tablet orally.

zsp1273 granules

Intervention Type: DRUG

Participants receive ZSP1273 granules orally.

Interventions

ZSP1273 tablet

Participants receive ZSP1273 tablet orally.

Intervention Type: DRUG

zsp1273 granules

Participants receive ZSP1273 granules orally.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZSP1273-22-09

Identifier Type: -

Identifier Source: org_study_id