Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03327558 · ClinicalTrials.gov registry record · Phase 1
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03327558: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT03327558 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03327558, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Primary Outcome
Maximum observed plasma concentration levels used for descriptive analysis
Interventions
- DRUG Apriso 0.375G ER CAP
- DRUG APRISO 375 mg extended-release capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2017-08-18 |
| Phase | Phase 1 |
What the finished NCT03327558 record still lists
NCT03327558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Apriso 0.375G ER CAP is the first listed.
NCT03327558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03327558 about?
NCT03327558 is a clinical study titled "Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects". The objective of this study is to evaluate and compare the bioavailability of mesalamine
What is the current status of trial NCT03327558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-05-15. Estimated completion is 2017-08-18.
What interventions are being tested in trial NCT03327558?
The interventions under investigation include: Apriso 0.375G ER CAP (DRUG), APRISO 375 mg extended-release capsules (DRUG).
Who is sponsoring clinical trial NCT03327558?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03327558's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
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