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Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

NCT01366352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-27

No results posted yet for this 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.

Conditions

  • Normal Volunteers

Interventions

DRUG

MNTX tablet (Formulation 1)

DRUG

MNTX tablet (Formulation 2)

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Tage Ramakrishna, MD · Progenics Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01366352 on ClinicalTrials.gov