Clinical trial
Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin
Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT07362030
Active, not recruitingPhase 1Interventional
What this study is about
The drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionObesity
Full registry criteria
Inclusion Criteria: 1. Body mass index (BMI) ≥20 to ≤35 kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared); 2. Ability to understand and willingness to sign a written informed consent form; 3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant. Exclusion Criteria: 1. Participants with a history of hypersensitivity to study drug or any component of study medication; 2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening; 3. Smoking more than 5 cigarettes per day within 12 weeks prior to screening,or who cannot stop using any tobacco products during the study period; 4. Participants who donated blood/bleeding profusely (\> 400 mL) 12 weeks prior to randomization; 5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms; 6. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse. 7. Females who are pregnant, lactating, or likely to become pregnant during the study. 8. History of dysphagia or any gastrointestinal disorder that affect absorption
Treatments and study arms
RAY1225
Drug
subcutaneous injection
atorvastatin calcium tablet
Drug
Oral
Metformin Tablets
Drug
Oral
Warfarin Sodium Tablets
Drug
Oral
Digoxin Tablets
Drug
Oral
Primary outcomes
Pharmacokinetic - CmaxDay 1~Day 5 and Day 86~Day 107
Maximum observed plasma concentration
Pharmacokinetic -Area under the curve(AUC)Day 1~Day 5 and Day 86~Day 107
Area under the curve
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Dongguan People's Hospital🇨🇳 Dongguan, China