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