None listed
Conditions
Brief summary
This will be a single-centre, multiple dose, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover bioequivalence study. Duration of the study is approximately 7 weeks; up to 3 weeks for screening and 29 days for study procedures, (6 consecutive treatment days for two dose application periods, with a minimum 2-week (14 day) washout period between and 1 day for study exit procedures).
Interventions
Single-centre, multiple dose, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover pivotal study with amitriptyline 5mg/g self applied to the vulva twice daily for 5 consecutive days and once on Day 6 separated by a washout period of 14 days in healthy women under steady state conditions.
The intervention for this trial is the test formulation of amitriptyline
The study medication will be self-applied in private at the In-patient facility at approximatel
Single-centre, multiple dose, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover pivotal study with amitriptyline 5mg/g self applied to the vulva twice daily for 5 consecutive days and once on Day 6 separated by a washout period of 14 days in healthy women under steady state conditions. The intervention for this trial is the test formulation of amitriptyline The study medication will be self-applied in private at the In-patient facility at approximately 8 am on Study Day 1 and at the Out-patient facility on Study Days 2-5 and at home at approximately 8 pm on Study Days 1-4 of both study periods. On the evening of Study Day 5 of each study period the participant is confined to our In-patient facility for a 1-night stay (about 25 hours on each occasion) for self-application of the study medication and Pharmacokinetic blood samples. Participants will be monitored for adverse events throughout the study. A diary will completed on a daily basis to record a Vulval Irritation Questionnaire and any adverse events experienced. Standard meals will be consumed at our In-Patient facility with no additional food intake allowed during confinement days. Pregnancy testing will be performed on Day 1 prior to dosing & alcohol breath testing, urine drugs of abuse will be performed upon each participant reporting to the In-patient facility on Day 5, 13 hours prior to dosing of each study period.. Pre and post study laboratory tests will be completed to assess the health of the participants along with drugs of abuse testing and pregnancy testing. Adherence to the study protocol will be done by weighing the gel before and after use.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Non-pregnant, assigned at birth females . Aged between 18 and 65 on day of consent BMI between 18.5 and 30.0 Non-smoker Drug free as determined by a Urine Drugs Test Normal, healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests Able to provide written informed consent in English Able to adhere to all study restrictions and attend all study visits Consent to GP being contacted if necessary
Exclusion criteria
Known history or presence of any clinically significant medical conditions Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results as determined by the Investigator. Women who are pregnant or plan to become pregnant in the next 3 months, or lactating females. History of genital herpes with >3 outbreaks per year or active non-HPV vaginal infection or vulval infections or irritations, thrush or lichen sclerosis. Had an abortion or miscarriage within the 3 months prior to randomisation. A known allergy, hypersensitivity, or intolerance to amitriptyline or Mi-Gel or its excipients. History of significant alcohol abuse within one year prior to date of consent or regular use of alcohol within six months prior to the date of consent History of significant drug abuse or dependency within one year prior to date of consent. Participation in a clinical research study within 30 days prior to Study Day 1 Use of medication other than topical products without significant systemic absorption. Prescription medication (except prescribed hormonal contraceptive) within 14 days prior to Study Day 1; Currently taking any of these medications - Alfuzosin, Amiodarone, dronedarone, Ranolazine, Fusidic Acid, Colchicine, Astemizole, terfenadine, Lurasidone, Pimozide, Quetiapine, Dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cisapride, Lovastatin, simvastatin, Avanafil, Sildenafil, Vardenafil, Oral midazolam, triazolam, St. John's wort. Over-the-counter products and natural health products within 7 days prior to Study Day 1, with the exception of prescribed hormonal contraception which does not contain Estriol. Donation of platelets or plasma within 30 days prior to Study Day 1. Participants who are not surgically sterile, post-menopausal or who are sexually active and not using effective contraception for the prevention of pregnancy (i.e. prescribed hormonal contraceptives or other reliable method) for at least 14 days prior to Study Day 1 until 7 days after the Study Exit visit. Participants of childbearing potential who use a hormonal contraceptive which contains Estriol. Participants who have poor venous access or cannot tolerate venepuncture, IV cannula insertion or who have a fear of needles or blood Any participant for whom the Investigator believes, for any reason, inclusion would not be an acceptable risk. Any clinically significant illness in the 30 days prior to Study Day 1.
Outcome results
None listed