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Diuretic

Treatment B for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)

Male and female participants must be 18 to 75 years of age, inclusive, at the time of signing the ICD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post dose

Awards & highlights

Study Summary

This trial is trying to understand how the body processes Spironolactone and Hydrochlorothiazide after taking tablets made by two different companies, Viatris and Neolpharma. They are

Who is the study for?

This trial is for healthy men and women aged 18-75, with a BMI of 16-32 kg/m2 and weight over 50 kg (110 lbs). It's not suitable for those outside these age, weight, or BMI ranges.Check my eligibility

What is being tested?

The study compares how the body processes Spironolactone/Hydrochlorothiazide tablets from two manufacturers: Viatris and Neolpharma. Participants will be randomly assigned to receive tablets from one of the companies.See study design

What are the potential side effects?

Potential side effects may include dehydration, electrolyte imbalance, dizziness, digestive issues like nausea or vomiting, muscle cramps, rash or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 16 and 32, and I weigh more than 110 pounds.

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUCinf (if data permit, otherwise AUClast)

Cmax

Secondary outcome measures

AUClast

Number of participants with Treatment Emergent Treatment-Related Adverse Events (AE's)

Number of participants with clinically significant change from baseline in Laboratory Abnormalities

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment BExperimental Treatment1 Intervention

Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets manufactured at Neolpharma.

Group II: Treatment AActive Control1 Intervention

Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets manufactured at Viatris.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma.

2023

Completed Phase 1

~50

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,832 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,000 Total Patients Enrolled

Frequently Asked Questions

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

What are the eligibility criteria for individuals to participate in this clinical study?

"To be considered eligible for this research study, potential participants must meet the criteria of being in good health and falling within the age range of 18 to 75. This trial has a capacity for a total enrollment of 40 individuals."

Answered by AI

Is the clinical trial open to individuals who are above 80 years old?

"Eligible candidates for this scientific investigation must be between 18 and 75 years old. It is worth noting that there are currently 56 clinical trials available exclusively for individuals under the age of 18, as well as an additional 369 studies specifically targeting patients over the age of 65."

Answered by AI

Are potential participants still able to enroll in this ongoing trial?

"As per the information found on clinicaltrials.gov, this particular trial is not seeking participants at present. The initial posting of the study was made on January 4th, 2024 and the most recent update occurred on January 11th, 2024. It's worth noting that while this specific trial is no longer recruiting patients, there are currently 760 other studies actively accepting participants."

Answered by AI

What is the level of patient safety associated with Treatment B?

"Treatment B is rated as a 1 on the safety scale by our team at Power. This rating reflects the fact that it is currently in Phase 1 of the trial, indicating limited data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma

2023. "A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205407.

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