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NCT Number: NCT01366352

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.

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Key information

Conditions

Normal Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MNTX tablet (Formulation 1)

Drug

MNTX tablet (Formulation 2)

Drug

Primary outcomes

  1. Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations

    Time frame: 7 days

    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 outcomes

  1. Half-life of MNTX administered as two different oral formulations

    Time frame: 7 days

    To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

  2. Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations

    Time frame: 7 days

    To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

  3. Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations

    Time frame: 7 days

    To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

  4. Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations

    Time frame: 7 days

    To determine and compare relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.

  5. Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 6, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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