- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196662
Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers (IBD98-M)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Safety population The safety population is defined as all subjects who received at least one dose of the study medication.
Pharmacokinetic Population The pharmacokinetic population will include all subjects completing at least 2 periods and for whom the pharmacokinetic profile can be adequately characterised.
Any subject with pre-dose concentrations for mesalamine will be excluded from the pharmacokinetic population for this analyte if the pre-dose concentration is greater than 5% of the Cmax value of that period for this subject.
Data from subjects who experienced emesis during the sampling interval and who were not withdrawn as per criterion established under section 9.10 may be evaluated after completion of the pharmacokinetic analysis. Any subject who experienced emesis within 2 times median Tmax of the current study (based on the Reference product) will be excluded from the statistical analysis. Data (concentrations and pharmacokinetic parameters) from subjects excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects withdrawn due to adverse events or vomiting episodes will be presented but excluded from descriptive statistics.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada, G1P0A2
- inVentiv Health Clinique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of age and older, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Qualified Investigator.
- the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- the absence of history or known pyloric stenosis.
- the absence of known gastric or duodenal ulcer.
- the absence of urinary tract obstruction.
Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
- intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration
- condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration
- hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study
- sterile male partner (vasectomized since at least 6 months).
- Capable of consent.
Exclusion Criteria:
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen at screening.
- History of allergic reactions to mesalamine, salicylates, aminosalicylates, hyaluronic acid, or other related drugs.
- Positive pregnancy test at screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
- prescription medication within 14 days prior to the first dosing;
- over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- a depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening.
- Breast-feeding subject.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
IBD98-M: mesalamine-sodium hyaluronate 200mg-28.75mg
X2
|
single adiministration
Other Names:
|
Experimental: Treatment B
IBD98-M without HA: Mesalamine 200mg X2
|
single adiministration
Other Names:
|
Experimental: Treatment C
Delzicol 200 mg X2
|
single adiministration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve in plasma of IBD98-M
Time Frame: Day 5
|
Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Denis Audet, M.D., inVentiv
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110200
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
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on IBD98-M:
-
HighField Biopharmaceuticals CorporationRecruiting
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | VaricellaFrance, Italy
-
Fundació Institut de Recerca de l'Hospital de la...Sheba Medical Center; iMinds; Semmelweis University; AQuAS, Agència de Qualitat...CompletedSchizophreniaSpain, Hungary, Israel
-
Samueli Institute for Information BiologyWilliam Beaumont Army Medical Center; Palmer Center for Chiropractic Research... and other collaboratorsUnknown
-
CicloMed LLCCmed Clinical ServicesCompletedAdvanced Solid TumorsUnited States
-
Tulane UniversityRecruitingDepression | AnxietyUnited States
-
Kreiskrankenhaus DormagenCompletedFeasibility of Measurement of a Neuromuscular Block at the m. TrapeziusGermany
-
University of the Incarnate Word59th Medical Wing; United States Naval Medical Center, San Diego; Madigan Army... and other collaboratorsCompletedPreterm Birth | Maternal | Infant, Low Birth Weight | Anxiety Fear | Prenatal DepressionUnited States
-
National Institute of Allergy and Infectious Diseases...Merck Sharp & Dohme LLCCompletedHIV Infections | MeaslesUnited States, Puerto Rico
-
Beth Israel Deaconess Medical CenterBrigham and Women's HospitalCompletedStress | Stress, Psychological | Sleep | Stress Physiology | Slow BreathingUnited States