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NCT01366352 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets
A Phase 1 study of Normal Volunteers, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01366352: Completed Phase 1 study of Normal Volunteers, sponsored by Bausch Health Americas.
NCT01366352 is a Phase 1 study of Normal Volunteers that has completed, run by Bausch Health Americas. The registered enrollment target is 24 participants, below the 1,457-participant average among 4 other Normal Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366352, a Phase 1 study of Normal Volunteers, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.
Primary Outcome
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Conditions Studied
Interventions
- DRUG MNTX tablet (Formulation 1)
- DRUG MNTX tablet (Formulation 2)
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-02 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
What the finished NCT01366352 record still lists
NCT01366352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,457-participant average among 4 other Normal Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Normal Volunteers appearing as the primary indexed condition, and to 2 interventions - of which MNTX tablet (Formulation 1) is the first listed.
NCT01366352 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01366352 about?
NCT01366352 is a clinical study titled "Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets". This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.
What is the current status of trial NCT01366352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-02. Estimated completion is 2004-03.
What conditions does trial NCT01366352 study?
This clinical trial studies the following conditions: Normal Volunteers.
What interventions are being tested in trial NCT01366352?
The interventions under investigation include: MNTX tablet (Formulation 1) (DRUG), MNTX tablet (Formulation 2) (DRUG).
Who is sponsoring clinical trial NCT01366352?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366352 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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