Trial Outcomes & Findings for A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma (NCT NCT06205407)
NCT ID: NCT06205407
Last Updated: 2025-03-21
Results Overview
Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.
COMPLETED
PHASE1
42 participants
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
2025-03-21
Participant Flow
Participant milestones
| Measure |
Sequence 1: Treatment A Followed by Treatment B
Participants randomized to sequence 1 received spironolactone/hydrochlorothiazide 25/25 milligram (mg) film coated tablets manufactured at Viatris (Treatment A) and Neolpharma (Treatment B) on Day 1 of Period 1 and Period 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
Sequence 2: Treatment B Followed by Treatment A
Participants randomized to sequence 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma (Treatment B) and Viatris (Treatment A) on Day 1 of Period 1 and Period 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Period 1
STARTED
|
21
|
21
|
|
Period 1
Treated
|
21
|
21
|
|
Period 1
COMPLETED
|
21
|
21
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
21
|
21
|
|
Washout
COMPLETED
|
21
|
21
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
21
|
21
|
|
Period 2
Treated
|
19
|
20
|
|
Period 2
COMPLETED
|
19
|
19
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1: Treatment A Followed by Treatment B
Participants randomized to sequence 1 received spironolactone/hydrochlorothiazide 25/25 milligram (mg) film coated tablets manufactured at Viatris (Treatment A) and Neolpharma (Treatment B) on Day 1 of Period 1 and Period 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
Sequence 2: Treatment B Followed by Treatment A
Participants randomized to sequence 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma (Treatment B) and Viatris (Treatment A) on Day 1 of Period 1 and Period 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
|
Period 2
Adverse Event
|
2
|
1
|
Baseline Characteristics
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
Baseline characteristics by cohort
| Measure |
All Participants
n=42 Participants
Participants randomized to sequence 1 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris and Neolpharma in Period 1 and 2, respectively. Participants randomized to sequence 2 received Spironolactone/Hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma and Viatris in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|
|
Age, Continuous
|
48.4 Years
STANDARD_DEVIATION 13.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Viatris.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
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
Spironolactone
|
28.73 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
—
|
|
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
Hydrochlorothiazide
|
177.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
—
|
PRIMARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
Maximum plasma concentration of Spironolactone and Hydrochlorothiazide after participants received a single oral dose of 25/25 mg film coated tablets manufactured at Neolpharma.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Cmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Spironolactone
|
25.57 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
—
|
|
Cmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Hydrochlorothiazide
|
179.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
—
|
PRIMARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
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
Spironolactone
|
53.60 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 44
|
—
|
|
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
Hydrochlorothiazide
|
1269 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
—
|
PRIMARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
AUCinf of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Spironolactone
|
52.52 ng*hr/mL
Geometric Coefficient of Variation 40
|
—
|
|
AUCinf of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Hydrochlorothiazide
|
1281 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
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
Spironolactone
|
2.252 Hour
Standard Deviation 1.3694
|
—
|
|
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
Hydrochlorothiazide
|
10.91 Hour
Standard Deviation 2.1620
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
t1/2 of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Spironolactone
|
2.413 Hour
Standard Deviation 1.9284
|
—
|
|
t1/2 of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Hydrochlorothiazide
|
10.17 Hour
Standard Deviation 1.7661
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
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
Spironolactone
|
1.00 Hour
Interval 0.5 to 3.0
|
—
|
|
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
Hydrochlorothiazide
|
2.48 Hour
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
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.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Tmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Spironolactone
|
1.00 Hour
Interval 0.417 to 3.97
|
—
|
|
Tmax of Spironolactone and Hydrochlorothiazide Following a Single Oral Dose of Spironolactone/Hydrochlorothiazide 25/25 mg Film Coated Tablet Manufactured at Neolpharma
Hydrochlorothiazide
|
2.00 Hour
Interval 1.02 to 4.05
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)Population: The safety analysis population included all participants who received at least 1 dose of any study treatment.
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 hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality TEAE
|
8 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-related TEAE
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)Population: The safety analysis population included all participants who received at least 1 dose of any study treatment.
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, significant additional concomitant drug treatment, or other therapy.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities Meeting AE Criteria (Without Regard to Baseline Abnormality)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)Population: The safety analysis population included all participants who received at least 1 dose of any study treatment.
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 additional concomitant drug treatment, or other therapy.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Number of Participants With Vital Signs Data Meeting AE Criteria
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)Population: The safety analysis population included all participants who received at least 1 dose of any study treatment.
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 rate: i.e., rate \<120 bpm; new onset type I second degree (Wenckebach) atrioventricular (AV) block of \>30-second duration; frequent premature ventricular contraction/complex (PVC), triplets, or short intervals (\<30 seconds) of consecutive ventricular complexes.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
n=40 Participants
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively. A washout period of at least 4 days was maintained between each treatment period.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting AE Criteria
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A
Treatment B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=41 participants at risk
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Viatris in Period 1 and 2, respectively.
|
Treatment B
n=40 participants at risk
Participants randomized to sequences 1 and 2 received spironolactone/hydrochlorothiazide 25/25 mg film coated tablets manufactured at Neolpharma in Period 1 and 2, respectively.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
2.5%
1/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
2.5%
1/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
General disorders
Influenza like illness
|
2.4%
1/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
0.00%
0/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
2.5%
1/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
2.5%
1/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
12.5%
5/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Presyncope
|
2.4%
1/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
0.00%
0/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
2.5%
1/40 • From Baseline up to 35 days after the last dose of study intervention (approximately 41 days)
The safety analysis population included all participants who received at least 1 dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER