Trial Outcomes & Findings for Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants (NCT NCT05525910)

NCT ID: NCT05525910

Last Updated: 2024-09-19

Results Overview

AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. 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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: 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 treatment period
• Results posted on: 2024-09-19

Participant Flow

A total of 15 participants were randomized and assigned to receive the study intervention.

Participant milestones

Measure	Sequence 5: Treatment E-> A-> B-> C Period 1: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 2: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 3: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 4: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 1: Treatment A-> B-> C-> D Period 1: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 2: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) fixed dose combination (FDC) tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 3: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 4: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (high drug loading \[HDL\]) under fasted conditions (Test 3). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 2: Treatment B-> C-> D-> E Period 1: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 2: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 3: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 4: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 3: Treatment C-> D-> E-> A Period 1: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 2: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 3: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 4: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 4: Treatment D-> E-> A-> B Period 1: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 2: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 3: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 4: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.
Period 1 STARTED	3	3	3	3	3
Period 1 COMPLETED	3	3	3	3	3
Period 1 NOT COMPLETED	0	0	0	0	0
Period 2 STARTED	3	3	3	3	3
Period 2 COMPLETED	3	3	3	3	3
Period 2 NOT COMPLETED	0	0	0	0	0
Period 3 STARTED	3	3	3	3	3
Period 3 COMPLETED	3	3	3	3	3
Period 3 NOT COMPLETED	0	0	0	0	0
Period 4 STARTED	3	3	3	3	3
Period 4 COMPLETED	2	3	3	2	2
Period 4 NOT COMPLETED	1	0	0	1	1

Reasons for withdrawal

Measure	Sequence 5: Treatment E-> A-> B-> C Period 1: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 2: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 3: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 4: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 1: Treatment A-> B-> C-> D Period 1: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 2: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) fixed dose combination (FDC) tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 3: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 4: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (high drug loading \[HDL\]) under fasted conditions (Test 3). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 2: Treatment B-> C-> D-> E Period 1: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 2: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 3: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 4: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 3: Treatment C-> D-> E-> A Period 1: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 2: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 3: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 4: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 4: Treatment D-> E-> A-> B Period 1: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 2: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 3: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 4: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.
Period 4 Per sponsor due to study timelines	1	0	0	1	1

Baseline Characteristics

Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants

Baseline characteristics by cohort

Measure	Sequence 1: Treatment A-> B-> C-> D n=3 Participants Period 1: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 2: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) fixed dose combination (FDC) tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 3: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 4: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (high drug loading \[HDL\]) under fasted conditions (Test 3). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 2: Treatment B-> C-> D-> E n=3 Participants Period 1: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 2: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 3: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 4: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 3: Treatment C-> D-> E-> A n=3 Participants Period 1: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Period 2: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 3: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 4: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 4: Treatment D-> E-> A-> B n=3 Participants Period 1: Treatment D: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3). Period 2: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 3: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 4: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Sequence 5: Treatment E-> A-> B-> C n=3 Participants Period 1: Treatment E: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4). Period 2: Treatment A: Single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference). Period 3: Treatment B: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1). Period 4: Treatment C: Single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2). Each enrolled participant participated in 4 study periods to receive 4 different treatments according to the sequence determined by randomization. On Day 1 of each period, participants received a single oral dose of treatment as per the randomization schedule and a minimum of 4 days washout was planned between each treatment.	Total n=15 Participants Total of all reporting groups
Age, Continuous	30.3 Years STANDARD_DEVIATION 2.52 • n=5 Participants	56.7 Years STANDARD_DEVIATION 4.16 • n=7 Participants	50.0 Years STANDARD_DEVIATION 10.58 • n=5 Participants	53.3 Years STANDARD_DEVIATION 17.10 • n=4 Participants	51.7 Years STANDARD_DEVIATION 6.51 • n=21 Participants	48.4 Years STANDARD_DEVIATION 12.64 • n=10 Participants
Age, Customized 18-44 years	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants
Age, Customized 45-64 years	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants
Age, Customized >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	13 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: 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 treatment period

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.

AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. 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.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
AUCinf of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	27040 nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 36	29350 nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 28	30680 nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 21	28200 nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 40	33660 nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: 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 treatment period

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.

AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
AUClast of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	26620 ng*hr/mL Geometric Coefficient of Variation 37	28890 ng*hr/mL Geometric Coefficient of Variation 28	30350 ng*hr/mL Geometric Coefficient of Variation 21	27630 ng*hr/mL Geometric Coefficient of Variation 42	33060 ng*hr/mL Geometric Coefficient of Variation 31

PRIMARY outcome

Timeframe: 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 treatment period

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.

Cmax was defined as maximum plasma concentration. Cmax for nirmatrelvir was observed directly from data.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Cmax of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	2709 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 47	3111 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34	3181 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 24	3051 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 42	3556 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 41

PRIMARY outcome

Timeframe: 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 treatment period

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.

AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. 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.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
AUCinf of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	3420 ng*hr/mL Geometric Coefficient of Variation 76	3230 ng*hr/mL Geometric Coefficient of Variation 81	3453 ng*hr/mL Geometric Coefficient of Variation 54	2921 ng*hr/mL Geometric Coefficient of Variation 85	4130 ng*hr/mL Geometric Coefficient of Variation 62

PRIMARY outcome

Timeframe: 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 treatment period

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.

AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for ritonavir was calculated by Linear/Log trapezoidal method.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
AUClast of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	3224 ng*hr/mL Geometric Coefficient of Variation 76	3044 ng*hr/mL Geometric Coefficient of Variation 84	3297 ng*hr/mL Geometric Coefficient of Variation 53	2735 ng*hr/mL Geometric Coefficient of Variation 87	3821 ng*hr/mL Geometric Coefficient of Variation 66

PRIMARY outcome

Timeframe: 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 treatment period

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.

Cmax was defined as maximum plasma concentration. Cmax for ritonavir was observed directly from data.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Cmax of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)	371.3 ng/mL Geometric Coefficient of Variation 67	334.2 ng/mL Geometric Coefficient of Variation 93	374.5 ng/mL Geometric Coefficient of Variation 47	319.5 ng/mL Geometric Coefficient of Variation 84	411.3 ng/mL Geometric Coefficient of Variation 77

SECONDARY outcome

Timeframe: From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (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. Treatment-emergent were events between first dose of study treatment and up to approximately 51 days that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Number of Participants With All-Causality and Treatment-Related TEAEs Number of participants with all-causality TEAEs	2 Participants	0 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of participants with all-causality SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of participants with treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With All-Causality and Treatment-Related TEAEs Number of participants with treatment-related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline up to Day 4 of Period 4 (approximately 17 days)

Population: Participants with at least one observation of the given laboratory test while on study treatment or during lag time.

Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, fibrinogen, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy and culture. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was defined as the last measurement taken prior to first dosing (Period 1 Day -1).

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=3 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=3 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=2 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=4 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=5 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Monocytes/Leukocytes (%) >1.2*upper limit of normal (ULN)	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Fibrinogen (mg/dL) >1.25*baseline	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis Neutrophils (10^9/L) <0.8*lower limit of normal (LLN)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline up to Day 4 of Period 4 (approximately 16 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Vital signs (temperature, pulse rate and blood pressure) were obtained with participants following at least 5 minutes of supine rest. Clinical significance of vital signs was determined at the investigator's discretion. Baseline was defined as pre-dose measurement taken on Day 1 of each period.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline up to 35 days after last dose of study treatment (ie, up to 51 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

A complete physical examination (PE) included, at a minimum, height, weight, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief PE included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinical significance of physical examination values was determined at the investigator's discretion.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Number of Participants With Clinically Significant Physical Examination Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline up to Day 4 of Period 4 (approximately 16 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

A 12-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion. Baseline was defined as pre-dose measurement taken on Day 1 of Period 1.

Outcome measures

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 Participants Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Nirmatrelvir/Ritonavir 300(2*150)/100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nirmatrelvir/Ritonavir 3*(100/33.3 mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n=11 participants at risk Participants received a single oral dose of nirmatrelvir/ritonavir 300 (2\*150)/100 mg commercial tablets under fasted conditions (Reference) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n=11 participants at risk Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 1 (low disintegrant) under fasted conditions (Test 1) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n=11 participants at risk Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\*\[150/50 mg\]) FDC tablets Test formulation 2 (high disintegrant) under fasted conditions (Test 2) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n=12 participants at risk Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (2\* \[150/50 mg\]) FDC tablets Test formulation 3 (HDL) under fasted conditions (Test 3) on Day 1 of each treatment period.	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n=12 participants at risk Participants received a single oral dose of nirmatrelvir/ritonavir 300/100 mg (3\*\[100/33.3 mg\]) FDC tablets Test formulation 4 under fasted conditions (Test 4) on Day 1 of each treatment period.
Gastrointestinal disorders Constipation	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	9.1% 1/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	8.3% 1/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	9.1% 1/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	16.7% 2/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)
Injury, poisoning and procedural complications Wound	9.1% 1/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/11 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	0.00% 0/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)	8.3% 1/12 • From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place