NCT06205407

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

A Single-dose, Open-label, Randomized, 2-way, Cross-over Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer From Viatris to Neolpharma, for Spironolactone/Hydrochlorothiazide Film Coated Tablets in Healthy Adult Participants Under Fasted Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris	Manufactured at Viatris
DRUG	Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma.	Manufactured at Neolpharma.

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2024-01-16
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study