Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets - Full Text View

Purpose

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.

Condition	Intervention	Phase
Normal Volunteers	Drug: MNTX tablet (Formulation 1) Drug: MNTX tablet (Formulation 2)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

Secondary Outcome Measures:

Half-life of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To determine and compare relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.

Enrollment:	24
Study Start Date:	February 2004
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 MNTX tablet	Drug: MNTX tablet (Formulation 1)
Experimental: Arm 2 MNTX tablet	Drug: MNTX tablet (Formulation 2)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366352

Locations

United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Study Director:

Tage Ramakrishna, MD

Progenics Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01366352 History of Changes
Other Study ID Numbers:	MNTX 1202
Study First Received:	May 27, 2011
Last Updated:	July 17, 2011
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013