P-One Clinic (Hachioji, Tokyo) is seeking female medical volunteers for an upcoming clinical study this May and June 2019.
Clinical studies (also called “clinical trials”) are scientific tests to check the efficacy and safety of new drugs, medical devices, and healthcare procedures. They are conducted with the cooperation of willing volunteers and governed by the strict legal and ethical guidelines of Good Clinical Practice (GCP).
Those who pass the initial selection will be invited to an information/consent session and screening health check (Apr 23rd or 26th). Volunteers who pass the screening will be invited to participate in a test of a drug. Starting in mid-May, they will stay at the clinic 3 times, for 4 nights each time, and return for a short follow up on June 25th (specific dates below).
PARTICIPATION REQUIREMENTS
Inclusion Criteria
For this study, we are looking for individuals who meet all the conditions below:
- Healthy female
- Aged 20 to 55 years at time of screening
- BMI (body mass index) 18.0 to 30.0 as measured at screening
- You are living in Japan with a valid residence card
- Your test results and medical background at the screening and on the day before dosing are suitable for the study
- Willing to consent to the study and able to abide by study requirements
If you meet any of the following conditions, you cannot participate in the study:
- You have a serious physical or psychological condition or a history of such a condition
- You test positive on either the drug, nicotine, or alcohol test at the screening or the day before dosing
- You test positive for hepatitis B, hepatitis C, syphilis, or HIV at the screening
- Non-smoker.
*Please note: these are only a summary of the main requirements.
SCHEDULE
A) Screening & Information Session
Volunteers need only attend one screening to be considered for the study.
Or
April 26th (Friday): 1:15 pm (lasts approximately 3 hours)
B) Overnight Clinic Stays & Follow Up
Volunteers will attend all three clinic stays and a final follow up, with 10 days between each. For all stays, volunteers will be admitted to the clinic on the afternoon of the first day, take the drug on the second day, and be released in the early afternoon on the final day.1st Clinic Stay: Tuesday May 14th – Saturday May 18th
2nd Clinic Stay: Tuesday May 28th- Saturday June 1st
3rd Clinic Stay: Tuesday June 11th- Saturday June 15th
Follow up: Tuesday June 25th (a health check in the morning for approximately 1 hour)
COMPENSATION
*All participants will be compensated for their transportation and time. Please email us or apply for details.
If you interested in joining this study, the first step is to register with MVN. Click the button below for our registration page. For questions, email info@medical-volunteer-network.com
Medical Volunteer Network (MVN) connects non-Japanese volunteers with P-One Clinic, a medical research center in western Tokyo that specializes in clinical studies. Since P-One Clinic was established in 2005, it has completed over 200 studies and more than 10 with non-Japanese volunteers.