Last updated: March 25, 2024
Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Healthy Volunteers
Treatment
Digoxin
Metformin
Rosuvastatin
Clinical Study ID
NCT06335134
SCW0502-1016
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, 18-45 years old, inclusive;
- BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
- Ability and willingness to participate in the study, give written informed consent,and comply with the study requirements and all protocol procedures.
Exclusion
Exclusion Criteria:
- Presence of clinically significant conditions (including but not limited torespiratory system, cardiovascular system, gastrointestinal system, endocrine system,immune system, integumentary system, nervous system, ENT or other related diseases);
- History of allergic diseases including asthma, urticaria or eczema, or history ofsensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
- Known difficulty in swallowing tablets or history of gastrointestinal diseasesaffecting drug absorption;
- History of receiving any procedures that might affect drug absorption, distribution,metabolism or excretion;
- History of acute or chronic pancreatitis;
- History of documented or suspected hypoglycemic episodes within 6 months prior toscreening;
Study Design
Total Participants: 56
Treatment Group(s): 5
Primary Treatment: Digoxin
Phase: 1
Study Start date:
July 14, 2023
Estimated Completion Date:
March 31, 2024
Study Description
Connect with a study center
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
ChinaActive - Recruiting
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