| Eligibility |
Inclusion Criteria:
1. Healthy adult participants who are 18 to 49 years of age (inclusive).
2. In good general health (no active or uncontrolled diseases or conditions) and is able
to consume the study product.
3. Have a body mass index between 18.5 to 24.9 kg/m2 (inclusive).
4. Have normal or acceptable to the investigator heart rate at screening.
5. Individuals with childbearing potential should have a negative pregnancy test at
baseline and must agree to practice an acceptable form of non-hormonal birth control
throughout the study, including but not limited to:
1. double-barrier method
2. non-hormonal intrauterine devices
3. complete abstinence from sexual intercourse that can result in pregnancy
4. vasectomy of partner at least 6 months prior to the first dose of study product
Individuals with the potential to impregnate others must agree to use condoms or
other acceptable methods to prevent pregnancy throughout the study. Complete
abstinence from sexual intercourse that can result in pregnancy is also
acceptable.
6. Must have suitable veins for repeated venipuncture.
7. Able to swallow pills or capsules whole and without chewing.
8. Willing and able to comply with the protocol, including:
- Agrees to consume the standardized meals provided at the site during Visit 2 and
Visit 3
- Agrees to fast overnight, i.e., no food or liquids for a minimum of 10 hours
prior to dosing (except for water, permitted up to 1-hour prior to dosing) on
Visit 2 and Visit 3
- Agrees to refrain from consuming grapefruit, pomelo, Seville orange, and
starfruit containing foods/beverages 7 days prior to Visit 2 and throughout the
study
- Agrees to refrain from caffeine/xanthine and alcohol or alcohol-containing
products 48 hours prior to dosing on Visit 2 and Visit 3
- Agrees to refrain from the use/application of treatments/procedures listed in the
protocol
- Agrees to maintain the same diet and exercise habits throughout the study
- Agrees not to donate blood or plasma for 30 days after completing the study
- Able to give voluntary consent
Exclusion Criteria:
1. Participants who are lactating, pregnant or planning to become pregnant during the
study.
2. Have a known sensitivity, intolerability, or allergy to any of the standardized study
meals/snacks, study products or their excipients.
3. Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study
period, current COVID-19 infections, or currently have the post COVID-19 condition as
defined by World Health Organization (i.e., individuals with a history of probable or
confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with
symptoms that last for at least 2 months and cannot be explained by an alternative
diagnosis). Note: screened participants who have received a COVID-19 vaccine 2 weeks
prior to screening would be eligible to participate after completing a 14-day washout
period.
4. Have uncontrolled or controlled high blood pressure (=140 systolic or =90 diastolic
mmHg) at screening.
5. Have a history of heart disease/cardiovascular disease, renal or hepatic
impairment/disease, diabetes (Type I or Type II), previously diagnosed or current
diagnosis of any psychiatric disorders, unstable thyroid disease, immune disorders
and/or immunocompromised (e.g. HIV/AIDS), cancer (except localized skin cancer without
metastases or in situ cervical cancer) within 5 years prior to the screening visit, or
any clinically significant disease or disorder which, in the opinion of the
investigator, may either put the potential participant at risk because of
participation in the study, or influences the results or the potential participant's
ability to participate in the study.
6. Major surgery with general anesthesia in the 3 months prior to screening or planned
major surgery during the course of the study.
7. Have a history of blood clotting disorders.
8. Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL
of blood within 30 days prior to the first pharmacokinetic visit or a blood donation
of more than 450 mL within 56 days prior to the first pharmacokinetic visit.
9. Reports donating plasma (e.g., plasmapheresis) within 15 days prior to the first
pharmacokinetic visit.
10. Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing
(e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease,
inflammatory bowel disease, chronic pancreatitis, steatorrhea).
11. Have gallstones, bile duct obstruction, stomach ulcers, excess stomach acid, or
gastroesophageal reflux disease.
12. History of alcohol or substance abuse in the 12 months prior to screening or use that
to the opinion of the Qualified Investigator may be of a concern for the study.
13. Receipt or use of test product(s) in another research study within 28 days prior to
baseline or longer if the previous test product is deemed by the investigator to have
lasting effects that might influence the eligibility criteria or outcomes of current
study.
14. Any other active or unstable medical conditions or use of medications/supplements/
therapies that, in the opinion of the investigator, may adversely affect the
participant's ability to complete the study or its measures or pose a significant risk
to the participant.
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