the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02821871

Enrollment

Registered

2016-07-04

Start date

2016-03-31

Completion date

2016-09-30

Last updated

2016-07-04

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

Conditions

Type 2 Diabetes

Brief summary

All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.

Interventions

DRUGSP2086

DIETARY_SUPPLEMENThigh fat diet

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 volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion criteria

* History of diabetes * History of heart failure or renal insufficiency * Urinary tract infections, or vulvovaginal mycotic infections * History of or current clinically significant medical illness as determined by the Investigator * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * Known allergy to SP2086 or any of the excipients of the formulation of SP2086

Design outcomes

Primary

Measure	Time frame	Description
The area under the plasma concentration-time curve (AUC) of SP2086	up to Day 12	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
The maximum plasma concentration (Cmax) of SP2086	up to Day 12	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid	up to Day 12	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in fecal	up to Day 12	—
The area under the plasma concentration-time curve (AUC) of SP2086 acid	up to Day 12	AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in urine	up to Day 12	—

Secondary

Measure	Time frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 12

Countries

China

Contacts

Primary ContactYanhua Ding, docter

dingyanhua2003@126.com0431-88782168

Outcome results

None listed

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