Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01442688 · ClinicalTrials.gov registry record · Phase 1

Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine

A Phase 1 study of Healthy, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
1
Study location

NCT01442688: Completed Phase 1 study of Healthy, sponsored by Shire.

NCT01442688 is a Phase 1 study of Healthy that has completed, run by Shire. The registered enrollment target is 62 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01442688, a Phase 1 study of Healthy, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Amoxicillin + MMX placebo
  • DRUG Amoxicillin + MMX mesalazine/mesalamine

Study Locations (1)

Kansas

  • PRA International - Lenexa

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2011-10-07
Est. Completion 2011-11-20
Phase Phase 1
Shire

245 total trials

What the finished NCT01442688 record still lists

NCT01442688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Amoxicillin + MMX placebo is the first listed.

NCT01442688 reports a single indexed study location in Kansas.

Frequently Asked Questions

What is clinical trial NCT01442688 about?

NCT01442688 is a clinical study titled "Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine". This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.

What is the current status of trial NCT01442688?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2011-10-07. Estimated completion is 2011-11-20.

What conditions does trial NCT01442688 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01442688?

The interventions under investigation include: Amoxicillin + MMX placebo (DRUG), Amoxicillin + MMX mesalazine/mesalamine (DRUG).

Who is sponsoring clinical trial NCT01442688?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01442688 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01442688's enrollment target sits among peer trials

62 361st of 1090 higher than 728 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03231150 · 62 participants · NA

    Plantar Fasciitis Randomized Clinical Control Trial

  • NCT03458676 · 62 participants · NA

    Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies

  • NCT03596086 · 62 participants · Phase 1

    HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

  • NCT03603405 · 62 participants · Phase 1

    HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01442688, the US trial registry maintained by the National Library of Medicine. NCT01442688 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.