| Primary | Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Rosuvastatin in Period 1 and 2 | | Pharmacokinetic (PK) parameter set included 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. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00058.62± 46
- OG00172.78± 48
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| | 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 |
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| Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage. | | | | | Ratio of adjusted geometric means | 131.18 | | | 2-Sided | 90 | 115.89 | 148.48 | | | | | Other | | |
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| Primary | Maximum Observed Concentration (Cmax) of Rosuvastatin in Period 1 and 2 | | PK parameter set included 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin in Period 1 and 2 | | PK parameter set included 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Time for Cmax (Tmax) of Rosuvastatin in Period 1 and 2 | | PK parameter set included 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. | Posted | | Median | Full Range | Hours | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Terminal Half-Life (t1/2) of Rosuvastatin in Period 1 and 2 | t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included 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. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hours | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Apparent Clearance (CL/F) of Rosuvastatin in Period 1 and 2 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | PK parameter set included 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. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Rosuvastatin in Period 1 and 2 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | PK parameter set included 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. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2 | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate and temperature. Temperature was measured by orally. Blood pressure was measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Days 1 and 3 of each period | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Number of Participants With Laboratory Abnormalities | Laboratory abnormalities criteria: a) Hematology: monocytes >1.2* upper limit of normal (ULN); b) Urinalysis: urine hemoglobin were >=1 and leukocyte esterase were >=1. | Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days) | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. | Safety analysis set consisted of all participants who received at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | | Count of Participants | | Participants | | Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days) | | | | ID | Title | Description |
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| OG000 | Period 1: Rosuvastatin 10 mg | Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning. | | OG001 | Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg | Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning. |
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