Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02892370

Enrollment

Registered

2016-09-08

Start date

2016-08-31

Completion date

2016-10-31

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR0302 fasted or fed), crossover study was to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR0302 and mass balance study in 14 healthy subjects.

Interventions

DRUGSHR0302

SHR0302 tablets (10 mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male * BMI:19-24 kg/m2, weight \> 50 kg. * Age:18-45

Exclusion criteria

* History of clinically significant laboratory results or disease. * History of alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame	Description
The maximum plasma concentration (Cmax) of SHR0302	up to 72 hrs postdose	up to 72 hrs postdose on day1 and day7
The area under the plasma concentration-time curve (AUC) of SHR0302	up to 72 hrs postdose	up to 72 hrs postdose on day1 and day7
The accumulative excretion rate of SHR0302 and its metabolites in urine and feces	up to 96 hrs postdose	up to 96 hrs postdose on day1 and day7

Secondary

Measure	Time frame	Description
The number of volunteers with adverse events as a measure of safety	up to Day 21	required last visit via telephone during D11 to D21

Countries

China

Contacts

Primary ContactChengyu Guan, MD

guanchengyu@hrs.com.cn86-21-50118402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026