Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Amoxicillin + MMX mesalazine/mesalamine; Drug: Amoxicillin + MMX placebo

• Registration Number: NCT01442688
• Lead Sponsor: Shire

Brief Summary

This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Study Start: 2011-10-07
• Primary Completion: 2011-11-20
• Study Completion: 2011-11-20
• Results First Submitted: 2012-08-16
• Results First Submitted QC: 2012-08-16
• Results First Posted: 2012-09-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amoxicillin + MMX mesalazine/mesalamine	Amoxicillin + MMX mesalazine/mesalamine	-
Amoxicillin + MMX placebo	Amoxicillin + MMX placebo	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) for Amoxicillin	Assessed over a 24-hour period starting post-dose on day 4	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.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin	Assessed over a 24-hour period starting post-dose on day 4	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.

Trial Locations

Locations (1)

PRA International; 🇺🇸 Lenexa, Kansas, United States