- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911298
Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
April 3, 2017 updated by: Tillotts Pharma AG
An Open Label, Single-site Pharmaco-Scintigraphic Phase I - Study in Healthy Subjects to Evaluate the Gastrointestinal Transit and Release Profile of Radio-labelled Metronidazole Benzoate Capsules
This is a Phase I, open label, single-site trial to evaluate the in vivo release characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to disintegrate in the large intestine.
This will be examined by means of metronidazole plasma levels and scintigraphic images in healthy subjects.
Overall, nine subjects will be evaluated for each formulation prototype.
Two formulation prototypes will be investigated.
Each subject will receive one radio-labelled capsule only.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Basel-Stadt
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Basel, Basel-Stadt, Switzerland, 4031
- University Hospital Basel, Phase I Research Unit
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-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects, male or non-pregnant, non-lactating females, between 18 and 55 years old. Females of child bearing potential must have a negative urine pregnancy test prior to the intake of study drug, and must use a hormonal (oral, implantable or injectable) or a double barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal with as a minimum of one year since the last menstrual period).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Voluntary signed informed consent must be obtained and documented.
- Accept not to use any kind of tobacco, including cigarettes nor E-Cigarettes or pipe smoking, nicotine replacements nor oral tobacco and not to consume any alcohol or drugs during screening, treatment and following two days.
Exclusion Criteria:
- Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
- Radiation exposure from clinical trials, including that from the present study and from diagnostic X-ray but excluding background radiation, exceeds 5 mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study.
- Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
- Clinically significant deviation of biochemistry or haematology parameters from the normal range
- History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
- Clinically relevant cardiovascular, renal, hepatic, metabolic, autoimmune, pulmonary and particularly gastrointestinal diseases, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
- Acute diarrhoea or constipation in the 14 days before the predicted first study day. If screening occurs >14 days before first study day, this criterion is to be determined on the first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to defecate more frequently than every three days.
- History of adverse reaction or allergy to metronidazole or any study drug or formulation components/ingredients.
- Hypersensitivity to imidazole derivatives
- History of any malignancy removed or adequately treated.
- History of alcohol or drug abuse.
- Donation of blood (or plasma) within the previous three months and donation of Plasma the last 14 days.
- Over-the-counter (OTC) and prescription medication (including laxatives, vitamins and natural herbal remedies including St. John's Wort) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicylic acid is permitted.
- Ingestion of grapefruit juice, coffee, caffeine containing beverages on treatment day.
- Failure to satisfy the Investigator to participate for any other reason.
- Known allergy to crustaceans (due to Chitosan)
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: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mucoadhesive formulation
A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation is administered to subject in fasted state
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Active Comparator: Non-mucoadhesive formulation
A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation is administered to subject in fasted state
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scintigraphic analysis of time of capsule disintegration
Time Frame: 3 days
|
3 days
|
Scintigraphic analysis of location of capsule disintegration
Time Frame: 3 days
|
3 days
|
Transit time of the released granules after capsule disintegration
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal plasma concentration (Cmax)
Time Frame: 3 days
|
3 days
|
Time to reach Cmax (Tmax)
Time Frame: 3 days
|
3 days
|
Area under the concentration-time curve
Time Frame: 3 days
|
3 days
|
Elimination rate constant (k)
Time Frame: 3 days
|
3 days
|
Apparent terminal half-live (t½)
Time Frame: 3 days
|
3 days
|
Lag time (t-lag)
Time Frame: 3 days
|
3 days
|
Time of first measurable concentration after dosing
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Manuel Haschke, MD, University Hospital Basel, Phase I Research Unit
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 (Actual)
November 25, 2016
Primary Completion (Actual)
March 6, 2017
Study Completion (Actual)
March 6, 2017
Study Registration Dates
First Submitted
September 2, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP-CTI-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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