- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969252
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers
January 24, 2018 updated by: Cosmo Technologies Ltd
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers. Single and Multiple Dose, Open Label, Pharmacokinetics and Safety Study
The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men and women, 18-55 year old inclusive
- Body Mass Index: 18.5-30 kgm2 inclusive
- 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
- 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 entire study
- Fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year.
For all female subjects, pregnancy test result had to be negative at screening and Day -1
Exclusion Criteria:
- ECG 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
- Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was 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
- Blood donation: blood donations for 3 months before this study
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than 1 drink a day for females and more than 2 drinks a day for males, defined according to the USDA Dietary Guidelines 2010), caffeine (more than 5 cups coffee/tea/day) or tobacco abuse (10 cigarettes a day)
- Abuse drug test: positive result at the drug test at screening or Day-1
- Alcohol test: positive alcohol breath test at Day -1
- Diet: abnormal diets (less than1600 or more than 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- Pregnancy (females only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Open label
Single and multiple dose, open label, pharmacokinetics and safety study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: Day 1
|
Cmax,0-24 h
|
Day 1
|
Cmax
Time Frame: Day 1
|
Cmax,0-6
|
Day 1
|
tmax
Time Frame: Day 1
|
tmax,0-24
|
Day 1
|
tmax
Time Frame: Day 1
|
tmax,0-6
|
Day 1
|
AUC
Time Frame: Day 1
|
AUC 0-24
|
Day 1
|
AUC
Time Frame: Day 1
|
AUC 0-6
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
November 14, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 21, 2016
Study Record Updates
Last Update Posted (Actual)
January 26, 2018
Last Update Submitted That Met QC Criteria
January 24, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB-01-11/27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Rifamycin SV-MMX® 600
-
Dr. Falk Pharma GmbHCompletedUncomplicated DiverticulitisGermany
-
RedHill Biopharma LimitedNot yet recruiting
-
RedHill Biopharma LimitedNot yet recruiting
-
Bradley ConnorEnrolling by invitationGastrointestinal Disease | Small Intestinal Bacterial Overgrowth | Gastrointestinal InfectionUnited States
-
Cosmo Technologies LtdBausch Health Americas, Inc.CompletedTraveler's DiarrheaGuatemala, Mexico
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterCompletedHepatic Encephalopathy | Cirrhosis, LiverUnited States
-
Cosmo Technologies LtdCompletedInfectious Diarrhoea
-
Cosmo Technologies LtdCompletedDiarrhea-predominant Irritable Bowel SyndromeBelgium, Germany, Italy, Spain
-
Dr. Falk Pharma GmbHCompletedTraveler's DiarrheaEcuador, Guatemala, India
-
National Taiwan University HospitalRecruiting