Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397144
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL RANDOMIZED SINGLE DOSE CROSSOVER STUDY TO DETERMINE THE BE OF NIRMATRELVIR FOLLOWING ORAL ADMINISTRATION OF FDC TABLETS RELATIVE TO THE PAXLOVID COMMERCIAL TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent
The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth These combination tablets are compared to the tablet formulation that is already in the market This study will be done under fasted conditions in healthy adult participants
This study is seeking participants who are
Male and non-pregnant female participants aged 18 years and above
with a body weight of more than 50 kilograms and Body Mass Index BMI between 16 to 32 kilograms per meter squared
are healthy as confirmed by medical history physical examination laboratory tests
The study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants
The study will consist of 4 treatments
Treatment A Single oral dose of nirmatrelvir plus ritonavir 150 1 150100 milligrams marketed tablets under fasted conditions Reference 1 Treatment B low dose strength Single oral dose of nirmatrelvir plus ritonavir 150100 milligrams 2 7550 milligrams combination tablets under fasted conditions Test 1 Treatment C Single oral dose of nirmatrelvirritonavir 300 2 150100 milligrams marketed tablets under fasted conditions Reference 2 Treatment D high dose strength Single oral dose of nirmatrelvirritonavir 300100 milligrams 2 15050 milligrams combination tablets under fasted conditions Test 2
All treatments will be given under fasted conditions Fasted condition means the participants would not have had anything to eat before taking the medicines
Around 28 participants will be enrolled in the study Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine Selected participants will be admitted to the clinical research unit CRU one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods
On Day 1 of each period participants will be given a single dose of study medicine nirmatrelvirritonavir 300100 mg or 150100 mg by mouth by chance Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine Participants will be discharged from the CRU on Day 3 of Period 4 after all the study related procedures have been completed
A follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine The study will look at the experiences of participants receiving the study medicine This will help to understand if the study medicine is safe and effective
The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth These combination tablets are compared to the tablet formulation that is already in the market This study will be done under fasted conditions in healthy adult participants
This study is seeking participants who are
Male and non-pregnant female participants aged 18 years and above
with a body weight of more than 50 kilograms and Body Mass Index BMI between 16 to 32 kilograms per meter squared
are healthy as confirmed by medical history physical examination laboratory tests
The study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants
The study will consist of 4 treatments
Treatment A Single oral dose of nirmatrelvir plus ritonavir 150 1 150100 milligrams marketed tablets under fasted conditions Reference 1 Treatment B low dose strength Single oral dose of nirmatrelvir plus ritonavir 150100 milligrams 2 7550 milligrams combination tablets under fasted conditions Test 1 Treatment C Single oral dose of nirmatrelvirritonavir 300 2 150100 milligrams marketed tablets under fasted conditions Reference 2 Treatment D high dose strength Single oral dose of nirmatrelvirritonavir 300100 milligrams 2 15050 milligrams combination tablets under fasted conditions Test 2
All treatments will be given under fasted conditions Fasted condition means the participants would not have had anything to eat before taking the medicines
Around 28 participants will be enrolled in the study Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine Selected participants will be admitted to the clinical research unit CRU one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods
On Day 1 of each period participants will be given a single dose of study medicine nirmatrelvirritonavir 300100 mg or 150100 mg by mouth by chance Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine Participants will be discharged from the CRU on Day 3 of Period 4 after all the study related procedures have been completed
A follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine The study will look at the experiences of participants receiving the study medicine This will help to understand if the study medicine is safe and effective
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None