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A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.

NCT06531811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the potential difference between pharmacokinetics (PK), safety, tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation.

Conditions

  • Healthy Participants

Interventions

DRUG

AZD8630 (test formulation) via test inhaler

Participants will receive AZD8630 via test inhaler.

DRUG

AZD8630 (reference formulation) via Monodose inhaler

Participants will receive AZD8630 via Monodose inhaler.

DEVICE

Test inhaler

Participants will receive AZD8630 via test inhaler.

DEVICE

Monodose inhaler

Participants will receive AZD8630 via Monodose inhaler.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2024-10-03
Completion
2024-10-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531811 on ClinicalTrials.gov