| Primary | AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions. |
| | Units | Counts |
|---|
| Participants | - OG00011
- OG00111
- OG00212
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00028670± 36
- OG00130780± 25
- OG00233170± 33
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water | | | | | Ratio (%) of Adjusted Geometric means | 107.35 | | | 2-Sided | 90 | 99.66 | 115.64 | | | | | Other | The ratio and 90% CI were expressed as percentages. | | |
|
| Primary | AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Primary | Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 |
|
| Primary | AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Primary | AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Primary | Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions | Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data. | The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 |
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Event | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator. | All participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. |
|
| Secondary | Number of Participants With Laboratory Abnormalities | Participants analyzed in the laboratory abnormalities were with at least one observation of the given laboratory test while on study treatment or during lag time. Number of participants with laboratory abnormalities were number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time. Hematology, chemistry, urinalysis and other (SARS-CoV-2 RT-PCR, Urine drug screening, Pregnancy test (β hCG), eGFR [CKD-EPI], aPTT, PT-INR, Fibrinogen, At Screening only: FSH, HBsAg, HBsAb, HBcAb, HCVAb, HIV) were assessed. | All participants who took at least 1 dose of study intervention were included in the safety analysis set. | Posted | | Count of Participants | | Participants | | Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce |
|
| Secondary | Number of Participants With Clinically Significant Vital Sign Values | Participants with clinically significant vital sign values were with at least one observation of vital signs, which met pre-specified criteria while on study treatment or during lag time. | All participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Screening, Day 1 of each period and early termination/discontinuation. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding |
|
| Secondary | Number of Participants With Clinically Significant Physical Examination Values | Participants with clinically significant physical examination values were with at least one observation of physical examination, which met pre-specified criteria while on study treatment or during lag time. | All participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Screening and Period 1 Day -1. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding |
|
| Secondary | Number of Participants With Clinically Significant Abnormal Electrocardiogram Values | Participants with clinically significant electrocardiogram (ECG) values were with at least one observation of ECG, which met pre-specified criteria while on study treatment or during lag time. | All participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Screening, Period 1 Day 1 and Period 4 Day 4. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets | Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG002 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. | | OG003 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding |
|
| Secondary | Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. | All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis. | Posted | | Mean | Standard Deviation | Units on a scale | | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Secondary | Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. | All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis. | Posted | | Mean | Standard Deviation | Units on a scale | | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Secondary | Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. | All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis. | Posted | | Mean | Standard Deviation | Units on a scale | | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Secondary | Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. | All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis. | Posted | | Mean | Standard Deviation | Units on a scale | | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|
| Secondary | Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles | Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable. | All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis. | Posted | | Mean | Standard Deviation | Units on a scale | | 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period. | | | | ID | Title | Description |
|---|
| OG000 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions. | | OG001 | Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce | Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions. |
|