Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Normal Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366352
• Other study ID #: MNTX 1202
• Status: Completed
• Phase: Phase 1
• Start date: February 2004
• Est. completion date: March 2004

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Weight between 55 and 85 kg

2. 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

3. Non-smokers.

Exclusion Criteria:

1. History of evidence of cardiovascular, gastrointestinal, hepatic, musculoskeletal, neurological, pulmonary, renal, or other significant chronic illness

2. History of asthma, allergic skin rash, significant allergy, or other immunologic disorder

3. Consumption of barbiturates or other inducers or inhibitors of CYP450

4. History or suspicion of alcohol or drug abuse.

Related Conditions & MeSH terms

• Normal Volunteers

Intervention

Drug:
• MNTX tablet (Formulation 1)

• MNTX tablet (Formulation 2)

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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