Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01442688
First received: September 26, 2011
Last updated: August 16, 2012
Last verified: August 2012
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Purpose
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone & in combination with MMX Mesalazine/mesalamine.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Amoxicillin + MMX placebo Drug: Amoxicillin + MMX mesalazine/mesalamine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ] [ Designated as safety issue: No ]AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
- Maximum Plasma Concentration (Cmax) for Amoxicillin [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ] [ Designated as safety issue: No ]Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
| Enrollment: | 62 |
| Study Start Date: | October 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Amoxicillin + MMX placebo |
Drug: Amoxicillin + MMX placebo
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
|
| Experimental: Amoxicillin + MMX mesalazine/mesalamine |
Drug: Amoxicillin + MMX mesalazine/mesalamine
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
Other Name: Lialda®
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
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
- 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).
- A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
- 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.
- A history of or current clinically relevant moderate or severe renal or hepatic impairment.
- A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
- Known or suspected intolerance or hypersensitivity to the investigational product or amoxicillin, closely related compounds, or any of the stated ingredients
- A history of, or current, pancreatitis
Contacts and Locations More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01442688 History of Changes |
| Other Study ID Numbers: | SPD476-114 |
| Study First Received: | September 26, 2011 |
| Results First Received: | August 16, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amoxicillin Mesalamine Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013