NCT06205407

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

Completed Phase 1 Results posted Last updated 21 March 2025

What this trial tests

Phase 1 trial testing Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris in Healthy Participants in 42 participants. Completed in 1 March 2024.

Timeline

26 December 2023

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	42
Start date	26 December 2023
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris — full drug profile →
• Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma. — full drug profile →

Conditions studied

• Healthy Participants — all drugs for Healthy Participants →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Viatris Primary · Pre-dose (0 hours [hrs]) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.

Spironolactone

Group	Value	95% CI
Treatment A	28.73	± 52

Hydrochlorothiazide

Group	Value	95% CI
Treatment A	177.8	± 33

Cmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma Primary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Neolpharma.

Spironolactone

Group	Value	95% CI
Treatment B	25.57	± 47

Hydrochlorothiazide

Group	Value	95% CI
Treatment B	179.2	± 33

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Viatris Primary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Area under the plasma concentration-time curve from time zero to infinity of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.

Spironolactone

Group	Value	95% CI
Treatment A	53.60	± 44

Hydrochlorothiazide

Group	Value	95% CI
Treatment A	1269	± 27

AUCinf of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma Primary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Area under the plasma concentration-time curve from time zero to infinity of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Neolpharma.

Spironolactone

Group	Value	95% CI
Treatment B	52.52	± 40

Hydrochlorothiazide

Group	Value	95% CI
Treatment B	1281	± 32

Plasma Elimination Half Life (t1/2) of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Viatris Secondary · Pre-dose (hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

t1/2 was defined as terminal elimination half-life. Plasma elimination half life of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.

Spironolactone

Group	Value	95% CI
Treatment A	2.252	± 1.3694

Hydrochlorothiazide

Group	Value	95% CI
Treatment A	10.91	± 2.1620

t1/2 of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma Secondary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

t1/2 was defined as terminal elimination half-life. Plasma elimination half-life of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Neolpharma.

Spironolactone

Group	Value	95% CI
Treatment B	2.413	± 1.9284

Hydrochlorothiazide

Group	Value	95% CI
Treatment B	10.17	± 1.7661

Time to Reach Cmax (Tmax) of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Viatris Secondary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

Time to reach maximum concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.

Spironolactone

Group	Value	95% CI
Treatment A	1.00	0.500 – 3.00

Hydrochlorothiazide

Group	Value	95% CI
Treatment A	2.48	1.00 – 4.00

Tmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma Secondary · Pre-dose (0 hrs) and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post dose

Time to reach maximum concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Neolpharma.

Spironolactone

Group	Value	95% CI
Treatment B	1.00	0.417 – 3.97

Hydrochlorothiazide

Group	Value	95% CI
Treatment B	2.00	1.02 – 4.05

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)

An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any adverse events occurring following start of treatment were considered as treatment emergent adverse event (TEAE). Treatment-related TEAEs were determined by the investigator. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitali

All-causality TEAE

Group	Value	95% CI
Treatment A	8
Treatment B	8

Treatment-related TEAE

Group	Value	95% CI
Treatment A	5
Treatment B	2

All-causality SAE

Group	Value	95% CI
Treatment A	0
Treatment B	0

Number of Participants With Laboratory Test Abnormalities Meeting AE Criteria (Without Regard to Baseline Abnormality) Secondary · From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)

Abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) that met AE reporting criteria were those that worsened from baseline and considered clinically significant in the medical and scientific judgment of the investigator. Laboratory abnormalities that met any of the following conditions must be reported as an AE: (1) was associated with accompanying symptoms; (2) required additional diagnostic testing or medical/surgical intervention; (3) led to a change in study dosing (outside of any protocol-specified dose adjustments) or discontinuation from the study, significan

Group	Value	95% CI
Treatment A	0
Treatment B	0

Number of Participants With Vital Signs Data Meeting AE Criteria Secondary · From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)

Abnormal vital sign measurement results (supine blood pressure, pulse rate) that met AE reporting criteria were those that worsened from baseline and considered clinically significant in the medical and scientific judgment of the investigator. Vital sign abnormalities that met any of the following conditions must be reported as an AE: (1) was associated with accompanying symptoms; (2) required additional diagnostic testing or medical/surgical intervention; (3) led to a change in study dosing (outside of any protocol-specified dose adjustments) or discontinuation from the study, significant add

Group	Value	95% CI
Treatment A	0
Treatment B	0

Number of Participants With Electrocardiogram (ECG) Data Meeting AE Criteria Secondary · From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)

Abnormal ECG results meeting AE reporting criteria were those that worsened from baseline, and considered clinically significant in the medical and scientific judgment of the investigator. ECG findings that may qualify as AE included: marked sinus bradycardia (rate \<40 beats per minute \[bpm\]) lasting minutes; new PR interval prolongation \>280 millisecond (ms); new prolongation of QT interval corrected using Fridericia's formula (QTcF) to \>480 ms (absolute); new prolongation of QTcF by \>60 ms from baseline; new onset atrial flutter or fibrillation, with controlled ventricular response rat

Group	Value	95% CI
Treatment A	0
Treatment B	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to 35 days after the last dose of study intervention (approximately 41 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A

Serious: 0/41 (0%)

Deaths: 0/41

Treatment B

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (8 terms — click to expand)

Reaction	System	Treatment A	Treatment B
Headache	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Influenza like illness	General disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Presyncope	Nervous system disorders	—	—
Syncope	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT06205407 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.