BridgeMD
A research study investigating how semaglutide and dapagliflozin act in your body when dosed in one tablet
EU CTIS ID: 2022-500007-52-00
What this study is testing
To confirm that oral semaglutide and dapagliflozin steady state pharmacokinetics are not influenced by each other when dosed in a fixed- dose combination compared to when dosed alone in healthy participants.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
You likely can't join if
- Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lives of the investigational medicinal product, whichever is longer) before randomisation
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
- Blood donation, plasma donation or blood draw, defined as any of the below: a) In excess of 400 mL within the past 90 days prior to the day of screening b) In excess of 50 mL within the past 30 days prior to the day of screening
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant
See the full eligibility criteria
- Male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lives of the investigational medicinal product, whichever is longer) before randomisation
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
- Blood donation, plasma donation or blood draw, defined as any of the below: a) In excess of 400 mL within the past 90 days prior to the day of screening b) In excess of 50 mL within the past 30 days prior to the day of screening
- History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.