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Benzodiazepine

Treatment Sequence AB for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

Awards & highlights

Study Summary

This trial will compare how much of a drug gets into the body when taken as a pill vs. as an inhaler.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration-time curve from time 0 to infinity (AUC) of alprazolam

Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of alprazolam

Maximum plasma concentration (Cmax) of alprazolam

Secondary outcome measures

Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs)

Percentage of study participants with treatment-emergent adverse events (TEAEs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Sequence BAExperimental Treatment2 Interventions

Study participants randomized into this arm will receive single dose of oral alprazolam followed by single dose of Staccato alprazolam at pre-specified time points in the sequence BA.

Group II: Treatment Sequence ABExperimental Treatment2 Interventions

Study participants randomized into this arm will receive single dose of Staccato alprazolam followed by single dose of oral alprazolam at pre-specified time points in the sequence AB.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Staccato alprazolam

2022

Completed Phase 1

~30

Oral alprazolam

2011

Completed Phase 3

~250

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,415 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,942 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Treatment Sequence BA pose a risk to those undergoing it?

"As a Phase 1 trial, which means that safety and efficacy have limited supporting data, Treatment Sequence BA was assigned an assessment of 1 on our organisation's scale."

Answered by AI

Does this experiment admit participants aged eighty-five or above?

"The criteria for taking part in this study restricts the age of participants to between 18 and 55. For younger patients, there are 51 different clinical trials available; whereas, those 65 or older have 353 options."

Answered by AI

What is the magnitude of the population being monitored for this research?

"Affirmative. According to the clinicaltrials.gov database, this medical research is currently searching for 20 participants from one centre. The trial was initially posted on December 28th 2022 and last updated on January 25th 2023."

Answered by AI

Are there any available slots for participants in this research study?

"Affirmative. Information hosted on clinicaltrials.gov indicates that the recruitment process for this medical trial is still in progress; it was initially posted on December 28th 2022, and most recently updated on January 25th 2023. The study requires a total of 20 participants from 1 site only to be enrolled."

Answered by AI

What demographic is eligible to participate in this experiment?

"This study is in search of 20 individuals who fall between the ages of 18 and 55 with overall good health. In order to be eligible, potential participants must meet a host of criteria; they must have normal results from medical evaluation including physical examination, laboratory tests and cardiac monitoring at screening or Day -1 in the first Treatment Period, possess body weight above 45 kg (females) and 50 kg (males), BMI within 18-35kg/m2 range, male patients should use contraception during treatment periods as well as 7 days after administration while female candidates need to follow contraceptive guidance for 30 days post IMP administration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants

2022. "A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626439.