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

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164431
• Other study ID #: ZSP1273-22-09
• Status: Completed
• Phase: Phase 1
• Start date: November 23, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 22, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• ZSP1273 tablet
Participants receive ZSP1273 tablet orally.
• zsp1273 granules
Participants receive ZSP1273 granules orally.

Locations

Country	Name	City	State
China	Guangdong 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	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
Primary	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
Primary	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	Number of participants with drug-related adverse events as assessed by CTCAE v5.0		Day 1 to Day 20