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COMPLETED Phase 4

Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

NCT04207840 · View on ClinicalTrials.gov ↗

Study Summary

To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.

Interventions

  • COMBINATION_PRODUCT Epinephrine (0.125 mg/inhalation)
  • COMBINATION_PRODUCT Epinephrine Injection Auto-Injector (0.3mg/0.3mL)
  • COMBINATION_PRODUCT Albuterol Sulfate (0.09 mg/inhalation)

Study Locations (1)

California

  • Amphastar Study Site 0035 — Cypress

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2019-12-09
Est. Completion 2019-12-23
Phase Phase 4

Sponsor

Amphastar Pharmaceuticals

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04207840

The ClinicalTrials.gov registry entry for NCT04207840 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Asthma appearing as the primary indexed condition, and to 3 interventions — of which Epinephrine (0.125 mg/inhalation) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04207840 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04207840 about?

NCT04207840 is a clinical study titled "Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals". To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.

What is the current status of trial NCT04207840?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2019-12-09. Estimated completion is 2019-12-23.

What conditions does trial NCT04207840 study?

This clinical trial studies the following conditions: Asthma, Pharmacokinetics, Anaphylaxis, Epinephrine, Albuterol. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04207840?

The interventions under investigation include: Epinephrine (0.125 mg/inhalation) (COMBINATION_PRODUCT), Epinephrine Injection Auto-Injector (0.3mg/0.3mL) (COMBINATION_PRODUCT), Albuterol Sulfate (0.09 mg/inhalation) (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04207840?

This trial is sponsored by Amphastar Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04207840 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial