Biological Availability
Conditions
Keywords
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir, Paxlovid
Brief summary
The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rBA of the nirmatrelvir/ritonavir oral powder formulation. The study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.
Interventions
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in water under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fasted condition
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Exclusion criteria
* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1. * Evidence or history of clinically significant hematological, 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). * Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome). * Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed. * Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. * Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period. * A positive urine drug test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
| AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated by linear/log trapezoidal method. |
| Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | Cmax was defined maximum observed concentration. Cmax for nirmatrelvir was observed directly from data. |
| AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
| AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated by linear/log trapezoidal method. |
| Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5. | Cmax was defined maximum observed concentration. Cmax for ritonavir was observed directly from data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Baseline up to 28 days after last dose of study intervention (ie, up to 48 days). | An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study intervention and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs included SAEs and all non-SAEs that occurred during the study. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Baseline up to Day 4 of Period 5 (approximately 20 days) | The following laboratory test abnormalities (without regard to baseline abnormality) were reported during the study: monocytes/leukocytes (percentage \[%\]) is larger than (\>) 1.2x upper limit of normal (ULN), specific gravity (scalar) \>1.030, and urine hemoglobin was larger or equal to (\>=) 1. |
| Number of Participants With Clinically Significant Vital Signs | Baseline up to Day 4 of Period 5 (approximately 20 days). | Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Vital signs were done predose, 2 hours and 6 hours post dose on Day 1 of each treatment period and also on Day 4 of Period 5. Clinical significance of vital signs was determined at the investigator's discretion. |
| Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | Baseline up to Day 4 of Period 5 (approximately 20 days). | A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant has rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion. |
| Number of Participants With Clinically Significant Physical Examination (PE) Values | Screening, Baseline up to Day 4 of Period 5 (approximately 20 days). | A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Completed PE were performed by trained medical personnel at the investigator site at Screening or Period 1 Day 1 only. A brief PE might be performed at other designated time points at the discretion of the investigator. Clinical significance of physical examination values was determined at the investigator's discretion. |
| AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
| Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period. | The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire. |
| Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period. | The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire. |
| Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period. | The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire. |
| Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period. | The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire. |
| Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period. | The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire. |
| AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir (under fasted/fed conditions) was calculated by linear/log trapezoidal method. |
| Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | Cmax was defined maximum observed concentration. Cmax for nirmatrelvir (under fasted/fed conditions) was observed directly from data. |
| AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
| AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir (under fasted/fed conditions) was calculated by linear/log trapezoidal method. |
| Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5. | Cmax was defined maximum observed concentration. Cmax for ritonavir (under fasted/fed conditions) was observed directly from data. |
Countries
Belgium
Participant flow
Pre-assignment details
A total of 12 participants were assigned to the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were enrolled in this study. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous Mean (SD) | 47.2 Years STANDARD_DEVIATION 8.88 |
| Age, Customized 18-44 Years | 4 Participants |
| Age, Customized 45-64 Years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 4 / 12 | 5 / 12 | 2 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 27090 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 18 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 30650 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 33030 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 24 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 34000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 32810 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 18 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [102.77, 124.53]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [110.75, 134.2]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [114.43, 137.61]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [110.42, 132.79]
Primary
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 4005 ng*hr/mL | Geometric Coefficient of Variation 37 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3876 ng*hr/mL | Geometric Coefficient of Variation 34 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3479 ng*hr/mL | Geometric Coefficient of Variation 40 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3986 ng*hr/mL | Geometric Coefficient of Variation 34 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3176 ng*hr/mL | Geometric Coefficient of Variation 30 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [87.31, 107.23]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [78.38, 96.26]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [87.39, 112.8]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [70.07, 89.73]
Primary
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated by linear/log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 26500 ng*hr/mL | Geometric Coefficient of Variation 20 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 30110 ng*hr/mL | Geometric Coefficient of Variation 23 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 32470 ng*hr/mL | Geometric Coefficient of Variation 25 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 33540 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 32410 ng*hr/mL | Geometric Coefficient of Variation 19 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [102.96, 125.4]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [111.02, 135.22]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [115, 139.27]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [111.11, 134.57]
Primary
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated by linear/log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3818 ng*hr/mL | Geometric Coefficient of Variation 38 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3663 ng*hr/mL | Geometric Coefficient of Variation 35 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3303 ng*hr/mL | Geometric Coefficient of Variation 40 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3371 ng*hr/mL | Geometric Coefficient of Variation 49 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 2959 ng*hr/mL | Geometric Coefficient of Variation 32 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [86.45, 106.44]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [77.96, 95.98]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [72.97, 106.83]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [64.04, 93.76]
Primary
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir was observed directly from data.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 2862 ng/mL | Geometric Coefficient of Variation 20 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 3156 ng/mL | Geometric Coefficient of Variation 26 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 4034 ng/mL | Geometric Coefficient of Variation 23 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 4287 ng/mL | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 4208 ng/mL | Geometric Coefficient of Variation 23 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [99.01, 122.82]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [126.57, 157.01]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [132.86, 168.96]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [130.4, 165.83]
Primary
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Cmax was defined maximum observed concentration. Cmax for ritonavir was observed directly from data.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 398.4 ng/mL | Geometric Coefficient of Variation 47 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 406.1 ng/mL | Geometric Coefficient of Variation 46 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 368.1 ng/mL | Geometric Coefficient of Variation 52 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 386.6 ng/mL | Geometric Coefficient of Variation 66 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 280.7 ng/mL | Geometric Coefficient of Variation 35 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)90% CI: [87.71, 118.44]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)90% CI: [79.52, 107.38]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)90% CI: [78.4, 120.1]
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [56.92, 87.19]
Secondary
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 34000 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 32810 ng*hr/mL | Geometric Coefficient of Variation 18 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [90.08, 103.37]
Secondary
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir (under fasted/fed conditions) was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 3986 ng*hr/mL | Geometric Coefficient of Variation 34 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 3176 ng*hr/mL | Geometric Coefficient of Variation 30 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [72.42, 85.07]
Secondary
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 33540 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 32410 ng*hr/mL | Geometric Coefficient of Variation 19 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [90.13, 103.59]
Secondary
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 3371 ng*hr/mL | Geometric Coefficient of Variation 49 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 2959 ng*hr/mL | Geometric Coefficient of Variation 32 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [69.45, 110.92]
Secondary
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
Cmax was defined maximum observed concentration. Cmax for nirmatrelvir (under fasted/fed conditions) was observed directly from data.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 4287 ng/mL | Geometric Coefficient of Variation 22 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 4208 ng/mL | Geometric Coefficient of Variation 23 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [87.28, 110.36]
Secondary
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
Cmax was defined maximum observed concentration. Cmax for ritonavir (under fasted/fed conditions) was observed directly from data.
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 386.6 ng/mL | Geometric Coefficient of Variation 66 |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions | 280.7 ng/mL | Geometric Coefficient of Variation 35 |
Comparison: Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)90% CI: [56.87, 92.68]
Secondary
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study intervention and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs included SAEs and all non-SAEs that occurred during the study.
Time frame: Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 4 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 3 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 5 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment-related TEAEs | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 2 Participants |
Secondary
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant has rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days).
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examination (PE) Values
A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Completed PE were performed by trained medical personnel at the investigator site at Screening or Period 1 Day 1 only. A brief PE might be performed at other designated time points at the discretion of the investigator. Clinical significance of physical examination values was determined at the investigator's discretion.
Time frame: Screening, Baseline up to Day 4 of Period 5 (approximately 20 days).
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Clinically Significant Physical Examination (PE) Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Signs
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Vital signs were done predose, 2 hours and 6 hours post dose on Day 1 of each treatment period and also on Day 4 of Period 5. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days).
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Clinically Significant Vital Signs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Clinically Significant Vital Signs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Clinically Significant Vital Signs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Clinically Significant Vital Signs | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Clinically Significant Vital Signs | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
The following laboratory test abnormalities (without regard to baseline abnormality) were reported during the study: monocytes/leukocytes (percentage \[%\]) is larger than (\>) 1.2x upper limit of normal (ULN), specific gravity (scalar) \>1.030, and urine hemoglobin was larger or equal to (\>=) 1.
Time frame: Baseline up to Day 4 of Period 5 (approximately 20 days)
Population: All participants who took at least 1 dose of study intervention and with at least 1 observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Specific gravity (scalar) >1.030 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine hemoglobin >=1 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Specific gravity (scalar) >1.030 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine hemoglobin >=1 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Specific gravity (scalar) >1.030 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine hemoglobin >=1 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 3 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine hemoglobin >=1 | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Specific gravity (scalar) >1.030 | 1 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Specific gravity (scalar) >1.030 | 0 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Monocytes/Leukocytes (%) >1.2x ULN | 2 Participants |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed) | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Urine hemoglobin >=1 | 1 Participants |
Secondary
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 75.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 75.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 72.1 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 66.2 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 57.0 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 72.0 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 56.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 66.5 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 55.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 58.2 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 56.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 61.4 Units on a scale |
Secondary
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 65.5 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 66.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 72.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 73.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 59.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 56.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 60.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 65.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 53.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 57.2 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 56.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 56.3 Units on a scale |
Secondary
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 73.5 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 74.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 72.6 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 64.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 56.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 65.0 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 62.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 66.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 56.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 55.9 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 57.1 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 55.8 Units on a scale |
Secondary
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 30.9 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 34.5 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 34.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 33.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 31.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 31.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 34.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 37.5 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 27.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 27.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 29.4 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 26.4 Units on a scale |
Secondary
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Time frame: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.
Population: All participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 31.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 33.9 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 36.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 31.0 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 25.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 36.3 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 29.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 29.9 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 20 minutes | 26.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 5 minutes | 29.8 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 10 minutes | 29.7 Units on a scale |
| Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted) | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | 1 minute | 32.4 Units on a scale |