NCT06205407
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
See it on ClinicalTrials.gov ↗42 people
50%
50%
21 womenmiddle line = equal numbers21 men
- Phase
- PHASE1
- Paid for by
- Pfizer
- Finished
- 2024-03-01
- Health conditions
- Healthy Participants
- Who could join
- Anyone
- Ages
- 18 Years – 75 Years
- Average age
- mean 48.4 Years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 71.4% · Black / African American 26.2% · American Indian / Alaska Native 2.4%
Women left out
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“Hepatic dysfunction defined as: Total bilirubin ≥1.5 × ULN (For Gilbert's syndrome, direct bilirubin \>ULN is exclusionary)”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…matological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).”
Study titles and rules are shown in their original English.