The current study is designed as a phase I multiple dose study to evaluate the
pharmacokinetics and bioavailability of [14C]-labelled oxytocin in healthy women.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02911480
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Non-smoking women of child bearing potential (WOCBP)
Body mass index (BMI) between ≥ 18.0 and ≤ 30.0 kg/m2
Subject must voluntarily sign a written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and before any study specific procedure
Subject must be in good physical and mental health as judged by the Investigator based on evaluation of medical and gynecological history, physical examination, clinical laboratory, ECG, and vital signs data
Subject is willing and able to comply with all conditions and requirements of the study
Lactation and/or pregnancy in the previous 6 months before screening, whichever is applicable
Intention to become pregnant during the study or within 1 months after the follow up visit
History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening
Any clinically significant abnormality following review of medical history, laboratory results and physical examination at screening as judged by the Investigator
Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of the study drugs
Contraindications for the use of oxytocin
Hypersensitivity to the active substances or to any of the excipients of the investigational product or reference therapy
Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anesthetics, vasoconstrictors/sympathomimetics and caudal anesthetics, vasopressin-like drugs
Use of any prescribed or over-the-counter medication within 14 days before Day 1
Administration of any other investigational drug within 3 months before Day 1 or participation in 3 or more clinical trials in the 10 months before Day 1
Loss of more than 500 milliliters (mL) blood during the 3 months before Day 1, or intention to donate blood in the 3 months after completing the study
Subjects with a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening
Subjects with a history of alcohol or drug abuse or with a positive result at screening, for tests of alcohol intake or drugs of abuse
All locations for NCT02911480
View full eligibility
Tris trial is registered with FDA with number: NCT02911480. The sponsor of the trial is Oxytone Bioscience BV and it is looking for 0 volunteers for the current phase.
Official trial title: Assessment of Pharmacokinetics and Bioavailability of Carbon-14 ([14C])-Labelled Oxytocin
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.