A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Mebendazole - fasted state (Treatment A) (Drug); Mebendazole - fed state (Treatment B) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
Summary
The purpose of the study is to evaluate the effect of food on the bioavailability (how much
medication is in your blood) of mebendazole from a single 500 mg oral dose of a
fast-disintegrating chewable tablet formulation of mebendazole in healthy adult
participants.
Clinical Details
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Concentration of mebendazole in blood and urine under fed and fasted condition
Secondary outcome: Number of participants with adverse events
Detailed description:
This is an open-label (the participant and the study physician know what the participant is
getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover
(method used to switch participants from one treatment arm to another in a clinical study)
study in approximately 16 healthy adult participants. Participants will receive study
medication under fed state first and later under fasted state or vice versa. The study
consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment
phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10
day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7
to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study
physician will check participant's general health during the study. Total duration of study
for each participant will be approximately 48 days.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must have signed an informed consent document
- Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active,
be practicing an effective method of birth control before entry and throughout the
study
- Woman must have a negative serum human chorionic gonadotropin pregnancy test at
screening; and a negative urine pregnancy test on Day - 1 of each treatment period
- Man must agree to use an adequate contraception method as deemed appropriate by the
investigator and to not donate sperm during the study and for 3 months after
receiving the last dose of study medication
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140
mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders, lipid abnormalities, significant pulmonary disease, including
bronchospastic respiratory disease, diabetes mellitus, renal or hepatic
insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any
other illness that the investigator considers should exclude the subject or that
could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or
urinalysis at screening or at admission to the study center on Day - 1 of each
Treatment Period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead
electrocardiogram at screening or at admission to the study center on Day - 1 of each
Treatment Period as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for paracetamol, oral contraceptives and hormonal replacement
therapy within 14 days before dosing in each treatment period
- Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine,
amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and Day 1
of the each treatment period
- History of clinically significant allergies, especially known hypersensitivity or
intolerance to lactose
Locations and Contacts
Merksem, Belgium
Additional Information
Starting date: February 2014
Last updated: June 26, 2014
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