NL-OMON51105
Completed
Not Applicable
An open-label study to assess the pharmacokinetics and safety/tolerability of pulsatile intra-vaginal delivery of a single dose of oxybutynin in healthy females - PK of intra-vaginal oxybutynin
iGalli BV0 sites8 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iGalli BV
- Enrollment
- 8
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible subjects must meet all of the following inclusion criteria at
- •1\. Willing to give written informed consent and willing and able to comply with
- •the study protocol;
- •2\. Female subjects of child bearing potential (women of child bearing
- •potential, WOCBP) aged between 18 and 45 years (inclusive)
- •Female postmenopausal subjects aged between 50 and 69 years (inclusive);
- •Postmenopausal status is defined as age \* 50 years and having \> 12 months
- •amenorrhoea in the absence of hormonal therapy that may cause amenorrhoea.
- •3\. Subject is in good general health, according to the investigator\*s judgement
- •based on vital signs, medical history, physical examination, and laboratory
Exclusion Criteria
- •Eligible subjects must meet none of the following exclusion criteria at
- •1\. (A history of) any clinically significant medical condition or
- •abnormalities, as judged by the investigator, in physical examination,
- •laboratory test results (including chemistry panel with hepatic and renal
- •panels, complete blood count, and urine dipstick) or electrocardiography (ECG).
- •In the case of uncertain or questionable results, tests performed during
- •screening may be repeated to confirm eligibility or judged by the investigator
- •to be clinically irrelevant for healthy subjects.
- •2\. Being a virgin.
- •3\. History of sexual abuse/violence.
Outcomes
Primary Outcomes
Not specified
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