Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Completed · Phase 1

Conditions studied: Normal Volunteers

In brief

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.

Key facts

Study ID

NCT01366352

Run by

Bausch Health Americas, Inc.

People needed

24

Starts

2004-02-01

Expected to finish

2004-03-01

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Progenics Pharmaceuticals, Inc. — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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