Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01366352

Enrollment

Registered

2011-06-06

Start date

2004-02-29

Completion date

2004-03-31

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Volunteers

Brief 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.

Interventions

DRUGMNTX tablet (Formulation 1)

DRUGMNTX tablet (Formulation 2)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations	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

Measure	Time frame	Description
Half-life of MNTX administered as two different oral formulations	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.
Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations	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.
Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations	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.
Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations	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.
Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026