A Randomized, Open-label, Two-period, Double Crossover, Single Center Study to Evaluate the Effect of High-fat Diet on the Pharmacokinetics of SY-004 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- SY-004 capsule
- Conditions
- Type 2 Diabetes
- Sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A randomized, open, two cycle, double crossover, single center study was conducted to evaluate the effect of high-fat diet on the pharmacokinetics of SY-004 in healthy subjects
Detailed Description
This study will evaluate the effect of high-fat diet on the pharmacokinetics of SY-004.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and sign the informed consent voluntarily.
- •Age on the day of signing the informed consent: healthy subjects aged 18 or above, both male and female.
- •At the time of screening, male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, 19.0 kg / m2 ≤ BMI ≤ 26.0 kg / m
- •Fasting blood glucose ≥ 3.9 mmol / L and \< 6.1 mmol / L.
- •From one month before the informed consent to three months after the last medication, the subjects and their partners had no plans to have a child, take effective contraceptive measures voluntarily, and donate sperm or eggs.
Exclusion Criteria
- •Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was currently in progress, or other medical trials were conducted. The researchers judged that it was not suitable for the trial.
- •In the past, there were serious systematic diseases or family history (including cardiovascular system, digestive system, urinary system, etc.), the researchers judged that the disease status could significantly change the absorption, distribution, metabolism and excretion of the drug used in the trial, or the risk of the subjects would be increased by taking the trial drug.
- •Allergic constitution, or food allergy history, or known to be allergic to study drug / similar drug.
- •Previous history of hypoglycemia.
- •Previous patients with postural hypotension.
- •The past five years have been positive for drug abuse, drug use history or urine drug screening results.
- •Those who donate blood or lose more than 400ml of blood within 4 weeks before screening, or who have received blood or blood component infusion within 4 weeks before screening, or who plan to donate blood components within 3 months after the end of the study.
- •Those who have history of syncope or blood sickness, who cannot tolerate venous puncture or have difficulty in blood collection.
- •Severe infection, trauma or surgical operation within 4 weeks prior to screening, or those who are scheduled to perform surgery during the study (including, but not limited to, dental operations).
- •Use any prescription, over-the-counter, herbal or health care product within 2 weeks prior to screening.
Arms & Interventions
Group-1
The subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration.
Intervention: SY-004 capsule
Group-2
The subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration.
Intervention: SY-004 capsule
Outcomes
Primary Outcomes
Cmax
Time Frame: 8 days
Under fasting and high-fat diet, Peak Plasma Concentration (Cmax) of SY-004 in human plasma.
AUC0-∞
Time Frame: 8 days
Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC)0 - ∞ of SY-004 in human plasma.
AUC0-t
Time Frame: 8 days
Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC) 0-t of SY-004 in human plasma.
Secondary Outcomes
- Tmax、t1/2z、CLz/F(8 days)
- t1/2z(8 days)
- CLz/F(8 days)