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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01442688 |
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Date of registration:
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26/09/2011 |
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Primary sponsor: |
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Public title:
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Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine
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Scientific title:
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A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Amoxicillin Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01442688 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Patrick Martin |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shire Development LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18-55 years inclusive at the time of consent. The date of signing informed
consent is defined as the beginning of the Screening Period.
2. Subject is willing to comply with any applicable contraceptive requirements of the
protocol and is:
- Male, or
- Non-pregnant, non-lactating female
- Females must be at least 90 days post-partum or nulliparous.
Exclusion Criteria
1. A history of current or recurrent disease that could affect the colon. This includes
gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac
disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel
Syndrome. Subjects who have a history of chronic constipation, which is physician
diagnosed and treated, will also be excluded from the study (frequency of bowel
movements >48 hours between samples).
2. A history of current or relevant serious, severe, or unstable (acute or progressive)
physical or psychiatric illness.
3. A history of gastrointestinal surgery performed within the past 12 months prior to
the first dose of investigational product, with the exception of an appendectomy.
4. A history of or current clinically relevant moderate or severe renal or hepatic
impairment.
5. A history of asthma or bronchospasm associated with the use of 5-ASA or other
non-steroidal anti-inflammatory drugs.
6. Known or suspected intolerance or hypersensitivity to the investigational product or
amoxicillin, closely related compounds, or any of the stated ingredients
7. A history of, or current, pancreatitis
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Amoxicillin + MMX mesalazine/mesalamine
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Drug: Amoxicillin + MMX placebo
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Primary Outcome(s)
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Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0?8) for Amoxicillin
[Time Frame: Assessed over a 24-hour period starting post-dose on day 4]
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Maximum Plasma Concentration (Cmax) for Amoxicillin
[Time Frame: Assessed over a 24-hour period starting post-dose on day 4]
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Secondary ID(s)
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SPD476-114
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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