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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SP2086; Dietary Supplement: high fat diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02821871

SP2086-110

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

SP2086

Active Comparator group

Description:

All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately.

Treatment:

Dietary Supplement: high fat diet

high fat diet

Other group

Description:

All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately.

Treatment:

Drug: SP2086