Medicines that may have different names or be made in different ways but have the sameeffect on the body are called bioequivalent.The purpose of this study is to learn about the bioequivalence of nirmatrelvir plusritonavir after taking 2 different combination tablet forms by mouth. These combinationtablets are compared to the tablet formulation that is already in the market. This studywill 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 ritonavircombination 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 × 150)/100 milligramsmarketed tablets under fasted conditions (Reference 1) Treatment B (low dose strength):Single oral dose of nirmatrelvir plus ritonavir 150/100 milligrams (2 × [75/50milligrams]) combination tablets under fasted conditions (Test 1) Treatment C: Singleoral dose of nirmatrelvir/ritonavir 300 (2 × 150)/100 milligrams marketed tablets underfasted conditions (Reference 2) Treatment D (high dose strength): Single oral dose ofnirmatrelvir/ritonavir 300/100 milligrams (2 × [150/50 milligrams]) combination tabletsunder fasted conditions (Test 2)All treatments will be given under fasted conditions. Fasted condition means theparticipants would not have had anything to eat before taking the medicines.Around 28 participants will be enrolled in the study. Healthy participants will be testedto 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 beforereceiving the study medicine and will remain in the CRU until discharge after completingall the treatment periods.On Day 1 of each period, participants will be given a single dose of study medicinenirmatrelvir/ritonavir 300/100 mg or 150/100 mg by mouth by chance. Study medicine willbe given with approximately 240 milliliters of room temperature water under fastedconditions (overnight fast of at least 10 hours and no food until 4 hours after receivingthe study medicine). Blood samples will be collected at different times of the day up to48 hours after taking the study medicine. Participants will be discharged from the CRU onDay 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 thefinal dose of the study medicine. The study will look at the experiences of participantsreceiving the study medicine. This will help to understand if the study medicine is safeand effective.
Not Provided
Drug: Paxlovid
Reference 1
Other Name: Nirmatrelvir/ritonavir commercial tablets
Drug: Paxlovid
Reference 2
Other Name: Nirmatrelvir/ritonavir commercial tablets
Drug: Nirmatrelvir/ritonavir
Test 1
Other Name: Nirmatrelvir/ritonavir FDC test tablets formulation 1
Drug: Nirmatrelvir/ritonavir
Test 2
Other Name: Nirmatrelvir/ritonavir FDC test tablets formulation 2
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and standard 12-lead ECG
(electrocardiogram).
- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
- Female participants of childbearing potential must have a negative pregnancy test at
screening and on Day -1.
- BMI (Body Mass Index) of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD (Informed consent Document) and in
this protocol.
Exclusion Criteria:
- Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV (Human Immunodeficiency Virus) infection, Hepatitis B, or Hepatitis
C; positive testing for HIV, HBsAg (Hepatitis B surface Antigen), HBcAb (Hepatitis B
core Antibody) or HCVAb (Hepatitis C Virus Antibody). Hepatitis B vaccination is
allowed.
- Any medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality or other conditions that
may increase the risk of study participation or, in the investigator's judgment,
make the participant inappropriate for the study.
- Use of prescription or nonprescription drugs and dietary and herbal supplements
within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study
intervention.
- Participants who have received a COVID-19 vaccine within 7 days before screening or
admission, or who are to be vaccinated with a COVID-19 vaccine at any time during
the study confinement period.
- A positive urine drug test.
Not Provided
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer