Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Study Overview
=================
Brief 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.

Official Title
-----------------
Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets: A Double-Blind, Single Dose, Crossover, Phase 1 Study in Normal Volunteers

Conditions
-----------------
Normal Volunteers

Intervention / Treatment
-----------------
* Drug: MNTX tablet (Formulation 1)
* Drug: MNTX tablet (Formulation 2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight between 55 and 85 kg In good health, based on history, physical examination, and appropriate laboratory and diagnostic tests at screening, with no evidence of clinically significant chronic medical condition Non-smokers. Exclusion Criteria: History of evidence of cardiovascular, gastrointestinal, hepatic, musculoskeletal, neurological, pulmonary, renal, or other significant chronic illness History of asthma, allergic skin rash, significant allergy, or other immunologic disorder Consumption of barbiturates or other inducers or inhibitors of CYP450 History or suspicion of alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>MNTX tablet | Drug: MNTX tablet (Formulation 1)<br> <br> |
| Experimental: Arm 2<br>MNTX tablet | Drug: MNTX tablet (Formulation 2)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Half-life of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days | 
| Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days | 
| Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days | 
| Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations | To determine and compare relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days | 
| Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics, relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |