Phase
Condition
Obesity
Diabetes Prevention
Treatment
NNC0487-0111 C
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)
Acetaminophen - 500 mg/15 ml
Clinical Study ID
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females of non-childbearing potential.
Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests performed during the screening visit, as judged by theinvestigator.
Exclusion
Exclusion Criteria:
Any disorder, unwillingness or inability which in the investigator's opinion mightjeopardise participant's safety or compliance with the protocol.
Any contraindications for the use of the oral contraception used in the studyaccording to the Microgynon Product Information.
Use of prescription medicinal products or non-prescription drugs including anyherbal medicine known to interfere with the metabolic CYP pathways, such ashypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening.
Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
History of major surgical procedures involving the stomach potentially affectingabsorption of trial products (e.g. subtotal and total gastrectomy, sleevegastrectomy, gastric bypass surgery) or current presence of gastrointestinalimplant.
Presence of clinically significant gastrointestinal disorders potentially affectingabsorption of drugs or nutrients, as judged by the investigator.
Study Design
Connect with a study center
Altasciences Clinical Company, Inc
Montreal, Quebec H3P 3P1
CanadaSite Not Available

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