Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Normal Volunteers

Treatments: Drug: MNTX tablet (Formulation 2); Drug: MNTX tablet (Formulation 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366352

MNTX 1202

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Arm 1

Experimental group

Description:

MNTX tablet

Treatment:

Drug: MNTX tablet (Formulation 1)

Arm 2

Experimental group

Description:

MNTX tablet

Treatment:

Drug: MNTX tablet (Formulation 2)