Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

Type 2 Diabetes Clinical Trial

Official title:

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353975
• Other study ID #: SHR3824-104
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2015
• Last updated: February 2, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy.

• BMI 18-25 kg/m2.

Exclusion Criteria:

• History of clinically significant illness.

• History of alcohol or drug abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SHR3824
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum plasma concentration (Cmax) of SHR3824	Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state	Day 1-4 on visit 2 and visit 3	No
Primary	The area under the plasma concentration-time curve (AUC) of SHR3824	AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state	Day 1-4 on visit 2 and visit 3	No
Primary	The accumulative excretion rate of SHR3824 and its metabolites in urine and feces	Accumulative excretion rate will be compared under fating state and fasted state	Day 1-4 on visit 2 and visit 3	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability.		Up to Day 12	Yes