Intestinal Obstruction Clinical Trial
Official title:
Effects of Extended Release Methylnaltrexone Bromide (150 mg b.i.d.) in Comparison to Extended Release Naloxone Hydrochloride (20 mg b.i.d.) on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time in Healthy Subjects.
The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral administration of methylnaltrexone and naloxone.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - age: 18 - 45 years - sex: male and female - ethnic origin: Caucasian - minimal body weight: 62 kg - body mass index:> 19 kg/m² and < 27 kg/m² - good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which were judged by the clinical investigator not to differ in a clinical relevant way from the normal state - written informed consent Exclusion Criteria: - hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication - gastrointestinal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication - drug or alcohol dependence - positive drug or alcohol screening - smokers of 10 or more cigarettes per day - positive results in HIV, HBV and HCV screenings - volunteers who are on a diet which could affect the pharmacokinetics of the drug - heavy tea or coffee drinkers (more than 1L per day) - lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception - volunteers suspected or known not to follow instructions of the clinical investigators - volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study - volunteers liable to orthostatic dysregulation, fainting, or blackouts - participation in a clinical trial during the last 3 months prior to the start of the study - less than 14 days after last acute disease - less than 3 months after last blood donation - any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors) - any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-life of the respective drug (except oral contraceptives) - intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication - known allergic reactions to the active ingredients used or to constituents of the study medication |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald | Greifswald | Mecklenburg-Vorpommern |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole-gut transit time (WGT) | Whole-gut transit time (WGT) was assessed by counting the radio-opaque markers with different shapes (Colon Transit) at different time pints in the feces. | up to 7 days after administration of the study medication | No |
Primary | renal clearance (CLR) | Blood sampling at 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h and urine sampling 48-60 h after administration of study medication | No | |
Primary | area under the curve of administration window (AUC0-12h) | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after administration of study medication | No | |
Primary | maximum concentration at steady state (Css max) | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after administration of study medication | No | |
Primary | minimum concentration at steady state (Css min) | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after administration of study medication | No | |
Primary | average concentration of administration interval (Cav) | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after administration of study medication | No | |
Primary | time of maximum concentration (Tmax) | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after administration of study medication | No | |
Secondary | Oro-cecal transit time (OCT) | Oro-cecal transit time (OCT) was defined as the first appearance of sulfapyridine in the plasma (cut of >100 ng/ml) after oral administration of 500 mg sulfasalazine immediate release tablets. | 48, 49, 50, 50.5, 51, 51.5, 52, 52.5, 53, 53.5, 54, 54.5, 55, 55.5, 56, 57, 58, 60, 62, 64 h after first administration of study medication | No |
Secondary | Colon transit time (CTT) | Colon transit time (CTT) was derived as the difference WGT minus OCT. | up to 7 days after administration of the study medication | No |
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