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

Phase 1

Completed

• Conditions: Bioequivalence
• Interventions: Drug: ZSP1273 tablet; Drug: zsp1273 granules

• Registration Number: NCT06164431
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ZSP1273 Sequence 1	zsp1273 granules	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.
ZSP1273 Sequence 2	ZSP1273 tablet	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.
ZSP1273 Sequence 2	zsp1273 granules	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.
ZSP1273 Sequence 1	ZSP1273 tablet	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China