Investigation aimed to evaluate the blood levels and the safety of Methylene Blue MMX® 25 mg modified-release tablets administered to healthy volunteers receiving two different bowel cleaning preparation for colonoscopy
- Conditions
- Bowel cleansing preparationDigestive System
- Registration Number
- ISRCTN16686064
- Lead Sponsor
- Cosmo Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and age: men and women, 50-65 year old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90
bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks
and side effects; ability to co-operate with the investigator and to comply with the requirements of the study
6. Fertility (women only): in post-menopausal status for at least 1 year
1. Electrocardiogram (12-leads, supine position): clinically significant abnormalities
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to methylene blue and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study and in particular asthma, anemia, deficiency of glucose-6-phosphate dehydrogenase and NADPH reductase or abnormal intestinal function, history of colorectal cancer or polyps; fecal occult blood positive patients
6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Concurrent or previous treatment, within 2 weeks before screening, with any of the prohibited psychiatric medications that may interact with methylene blue as listed in the drug safety alert
published by the US FDA, which include selective serotonin reuptake inhibitors (SSRI), serotoninnorepinephrine reuptake inhibitors (SNRI), tricyclic anti-depressants or monoamine oxidase A inhibitors and other psychiatric drugs. Previous or concomitant treatment with fluoxetine within 5 weeks prior to screening, and/or previous or concomitant treatment with anticoagulants or antiaggregant agents inducing an international normalized ratio (INR) > 1.5
7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
8. Blood donation: blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015), caffeine (>5 cups coffee/tea/day) or tobacco abuse (=6 cigarettes/day)
10. Drug test: positive result at the abuse drug test at screening or day -1
11. Alcohol test: positive alcohol breath test at day -1
12. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
13. Pregnancy (females only): positive or missing pregnancy test at screening
14. Previous study of methylene blue: subject enrolled in a previous study of methylene blue
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method