A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan® 4 mg/0.1 mL Nasal Spray Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04713709

Enrollment

Registered

2021-01-19

Start date

2021-01-31

Completion date

2021-10-10

Last updated

2022-05-02

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

Conditions

Opioid Overdose

Keywords

Naloxone, Nasal, Powder

Brief summary

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.

Detailed description

A comparison between FMXIN001 4 mg and Narcan® 4 mg/0.1 mL Nasal Spray under Fasting Conditions. A pharmacokinetic study in healthy volunteers

Interventions

COMBINATION_PRODUCTNasus Pharma FMXIN001

A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device

COMBINATION_PRODUCTNasal Naloxone liquid spray

A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Open-label, single-dose, randomized, two-period, two treatment, two-sequence, crossover, comparative bioavailability study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Healthy, non-smoking, male and female subjects, 18 years of age or older. 2. BMI ≥18 and ≤30 kg/m2. 3. Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant * Non-childbearing potential: * Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or * Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause). 4. Willing to use acceptable, effective methods of contraception. 5. Able to tolerate venipuncture. 6. Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion criteria

* The following

Design outcomes

Primary

Measure	Time frame	Description
Unconjugated naloxone in plasma - Tmax	0 to 8 hours post dose	Pharmacokinetic Parameters
Unconjugated naloxone in plasma - K el	0 to 8 hours post dose	Pharmacokinetic Parameters
Unconjugated naloxone in plasma- T half	0 to 8 hours post dose	Pharmacokinetic Parameters
Unconjugated naloxone in plasma - Cmax	0 to 8 hours post dose	Pharmacokinetic Parameters
Unconjugated naloxone in plasma - AUC	0 to 8 hours post dose	Pharmacokinetic Parameters

Secondary

Measure	Time frame	Description
Blood pressure	pre-dose	Safety Monitoring: Vital signs
Adverse events	0 to 24 hour post dose	Safety Monitoring
Pulse	pre-dose	Safety Monitoring: Vital signs
12-Lead ECG	pre-dose	Safety Monitoring
4-item NHANES Pocket Smell Test	pre-dose	Safety Monitoring
Nasal examination	pre-dose	Safety Monitoring

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026