A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.

September 30, 2024 updated by: Pfizer

A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.

The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201107
        • Huashan Hospital,Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Chinese participants
  • No clinical relevant abnormalities
  • Body mass index (BMI):17.5-28

Exclusion Criteria:

  • Any clinical significant illness
  • History of alcohol abuse
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
  • Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
  • Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
  • Blood donation within 60 days
  • History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
  • Other medical or psychiatric may inappropriate for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PF-07321332/ritonavir
PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers
Drug: PF-07321332/ritonavir
PF-07321332/ritonavir will be given by mouth two times a day for 10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Cmax is maximum plasma concentration .
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Cmax is maximum plasma concentration
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Tmax is the time for maximum plasma concentration
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Tmax is the time for maximum plasma concentration
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Area under the plasma concentration-time profile from time Zero to time point on 12 hours
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by AUCtau/tau.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
PF-07321332 Peak-to-trough Ratio (PTR) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by Day 10 Cmax/Day 10 Ctrough.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Apparent Clearance (CL/F) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral clearance. This was determined by Dose/AUCtau.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral volume of distribution.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
PF-07321332 Terminal Elimination Half-life (t½) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)
PF-07321332 Trough Concentration (Ctrough) on Day 5
Time Frame: Day 5 (pre-dose)
Concentration at pre-dose on Day 5. Observed directly from data.
Day 5 (pre-dose)
PF-07321332 Trough Concentration (Ctrough) on Day 8
Time Frame: Day 8 (pre-dose)
Concentration at pre-dose on Day 8. Observed directly from data.
Day 8 (pre-dose)
PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)
Time Frame: Day 10 (pre-dose)
Concentration at pre-dose on Day 10. Observed directly from data.
Day 10 (pre-dose)
PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
Time Frame: Day 10 (12 hours after last dose)
Concentration at 12 hour time on Day 10. Observed directly from data.
Day 10 (12 hours after last dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From baseline up to Day 42
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.
From baseline up to Day 42
Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria
Time Frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease >= 30 mmHg, max. increase >=30 mmHg; diastolic BP min. <50mmHg; diastolic BP change from baseline max. decrease >=20, max. increase >=20; seated pulse rate min. <40 beats per minute (bpm) and max. >120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
Number of Participants With Laboratory Abnormalities
Time Frame: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.
Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.
Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria
Time Frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds[msec]) >450 and ≤480, or >480 and ≤500, or >500; Increase from baseline in QTcF (msec) >30 and ≤60, or>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline >200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Cmax is maximum plasma concentration
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Cmax is maximum plasma concentration
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Tmax is the time for maximum plasma concentration
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Tmax is the time for maximum plasma concentration
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
Time Frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
This was determined by AUCtau/tau.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Apparent Clearance (CL/F) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral clearance. This was determined by Dose/AUCtau.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Apparent oral volume of distribution. This was determined by Dose/(AUCtau*kel)
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
Ritonavir Terminal Elimination Half-life (t½) on Day 10
Time Frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)
Ritonavir Trough Concentration (Ctrough) on Day 5
Time Frame: Day 5 (pre-dose)
Concentration at pre-dose on Day 5. Observed directly from data.
Day 5 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 8
Time Frame: Day 8 (pre-dose)
Concentration at pre-dose on Day 8. Observed directly from data.
Day 8 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)
Time Frame: Day 10 (pre-dose)
Concentration at pre-dose on Day 10. Observed directly from data.
Day 10 (pre-dose)
Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
Time Frame: Day 10 (12 hours after last dose)
Concentration at 12 hour on Day 10. Observed directly from data.
Day 10 (12 hours after last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4671016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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