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NCT06205407 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT06205407 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 42 participants.
The verdict
NCT06205407, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by mouth. The study is seeking for: * Both male and female participants. * participants who must be 18 to 75 years of age. * Body Mass Index of participants should be 16 to 32 kilogram per meter squared and body weight should be more than 50 kilograms (110 pounds). About 40 participants will enter the study (20 in each group). Study consists of two periods. On Day 1 of each period, participants will receive a single amount of Spironolactone and Hydrochlorothiazide tablets. The total duration of study will be 71 days. Follow up may occur via telephone after 35 days after taking the final tablet of the study medicine.
Interventions
- DRUG Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris
- DRUG Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2023-12-26 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06205407
The ClinicalTrials.gov registry entry for NCT06205407 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris is the first listed.
NCT06205407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06205407 about?
NCT06205407 is a clinical study titled "A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma". The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by mouth. The study is seeking for: * Both male and female participants....
What is the current status of trial NCT06205407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2023-12-26. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT06205407?
The interventions under investigation include: Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris (DRUG), Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma. (DRUG).
Who is sponsoring clinical trial NCT06205407?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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