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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: Completed Phase 1 study, sponsored by Pfizer.
NCT06205407 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.
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 |
What the finished NCT06205407 record still lists
NCT06205407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06205407's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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