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NCT Number: NCT07362030

Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin

The drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dongguan People's Hospital

Dongguan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • Ability to understand and willingness to sign a written informed consent form;
  • Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion criteria

  • Participants with a history of hypersensitivity to study drug or any component of study medication;
  • Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening;
  • 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;
  • Participants who donated blood/bleeding profusely (> 400 mL) 12 weeks prior to randomization;
  • Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
  • Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • History of dysphagia or any gastrointestinal disorder that affect absorption

Treatment and study plan

RAY1225

Drug

subcutaneous injection

atorvastatin calcium tablet

Drug

Oral

metformin tablets

Drug

Oral

Warfarin Sodium Tablets

Drug

Oral

Digoxin Tablets

Drug

Oral

Primary outcomes

  1. Pharmacokinetic - Cmax

    Time frame: Day 1~Day 5 and Day 86~Day 107

    Maximum observed plasma concentration

  2. Pharmacokinetic -Area under the curve(AUC)

    Time frame: Day 1~Day 5 and Day 86~Day 107

    Area under the curve

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: DAY 1~Day 107

    The safety and tolerability of RAY1225 alone and in combination with IWarfarin, atorvastatin, metformin and digoxin will be examined.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Open-Label, Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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