Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions

NCT ID: NCT03973632

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2019-12-31

Brief Summary

To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.

Detailed Description

By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.

Conditions

Healthy Volunteer

Study Design

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

Study Groups

Group A

Fasting at last 10h before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.

Group Type: EXPERIMENTAL

SH-1028 Tablets

Intervention Type: DRUG

200mg of SH-1028 Tablets, orally once every cycle.

Group B

Feeding with high-fat diet within 30 minutes before taking 200mg（two pills）of SH-1028 tablets on Day 1 of cycle 1，Fasting at last 10h before taking 200mg（two pills） of SH-1028 tablets on Day 1 of cycle 2. Each cycle is 4 days with a 3-days interval.

Group Type: EXPERIMENTAL

SH-1028 Tablets

Intervention Type: DRUG

200mg of SH-1028 Tablets, orally once every cycle.

Interventions

SH-1028 Tablets

200mg of SH-1028 Tablets, orally once every cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Subject with acceptable laboratory results.

2. BMI between 19 and 26; Weight between 50 and 80 kg

3. Not allowed to smoke or drink during the trial.

4. Subject should be willing to contracept during the study and until 6 months after completion of study.

Exclusion Criteria

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.

2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity

3. Addicted to smoking and drinking.

4. Hemorrhage over 200mL in 3 months before the trial.

5. Other conditions not suitable for trial, by judgement of investigator.

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

Sponsors

Nanjing Sanhome Pharmaceutical, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhou Huan, associate professor

Role: CONTACT

zhouhuan@bbmc.edu.cn

13665527160

Other Identifiers

SHC013-I-03

Identifier Type: -

Identifier Source: org_study_id