| Eligibility |
Inclusion Criteria:
- 18 to 50 years of age inclusive
- Participant does not have a known allergy to the drug under investigation, any of its
ingredients or any other related drugs.
- Normal vital signs after up to 10 minutes resting in supine position or 2 minutes in
sitting position: 100 millimeter of mercury (mmHg) =< systolic blood pressure (SBP)
<130 mmHg; 70 mmHg =< diastolic blood pressure (DBP) <90 mmHg; 60 beats per minute
(bpm) =< Pulse rate (HR) =< 100 bpm.
- Normal standard 12-lead ECG after 10 minutes resting in supine position in the
following ranges; 120 milliseconds (ms)<PR<220 ms, QRS<120 ms, corrected QT interval
(QTc)=<450 ms, and normal ECG tracing unless the Investigator considers an ECG tracing
abnormality to be not clinically relevant.
- Laboratory parameters within the normal range (or defined screening threshold for the
Investigator site), unless the Investigator considers an abnormality to be clinically
irrelevant for healthy participants; however serum creatinine, alkaline phosphatase,
hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should not
exceed 1.25 times the upper laboratory norm, and total bilirubin should not exceed the
upper laboratory normal (Laboratory tests are performed not longer than two weeks
before the initiation of the clinical study).
- Body weight on 45 kilogram (kg) or more and body mass index (BMI) within the range
18.5-30 kilogram per meter square (kg/m^2) (inclusive).
- Healthy Adult, Male and Female (woman of non-childbearing potential [WONCBP]); a) Male
participants are eligible to participate if they agree to the following during the
study intervention period and for at least 30 days after the last dose of the study
drug. Refrain from donating sperm PLUS, either: Be abstinent from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long term and
persistent basis) and agree to remain abstinent OR Must agree to use
contraception/barrier as detailed in the protocol; Agree to use a male condom and
should also be advised of the benefit for a female partner to use a highly effective
method of contraception as a condom may break or leak when having sexual intercourse
with a woman of childbearing potential who is not currently pregnant, agree to use a
male condom when engaging in any activity that allows for passage of ejaculate to
another person. Contraceptive use by Men should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Female Participants: is eligible to participate if: Is a WONCBP as defined in the
protocol. Additional requirements for testing are listed in the protocol. The
investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a woman with an early
undetected pregnancy. Female participants must use a double contraception method
including a highly effective method of birth control, except if she has undergone
sterilization at least 3 months earlier or is postmenopausal.
- Capable of giving signed informed consent as described in the protocol.
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular including history of
hypotension and orthostatic hypotension, pulmonary, gastrointestinal, hepatic, renal,
metabolic, hematological, neurological, osteomuscular, articular, psychiatric,
systemic, ocular or infectious disease, or signs of acute illness, lactose
intolerance.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice
a month).
- Blood donation, any volume, within 2 months.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or
asymptomatic postural hypotension defined as a decrease in systolic blood pressure
>=30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and
treated by a physician. Participants with known hypersensitivity to any component of
the investigational medicinal product (IMP) formulation or allergic disease diagnosed
and treated by a physician.
- History of drug or alcohol abuse. History of regular alcohol consumption within one
year of the study defined as: an average weekly intake of >14 drinks. One drink is
equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5
ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop
smoking during the study (occasional smoker can be enrolled). Excessive consumption of
beverages containing xanthine bases [more than 4 cups or glasses (average 100 mL) per
day].
- Use of any prescribed medication, over the counter (OTC) medicines or medicinal
products during the last two weeks preceding the first dosing and until discharge from
the study.
- Participation in a bioequivalence study or in a clinical study within the last 60 days
(2 months) before first study drug administration.
- Positive result on any of the following tests: hepatitis B surface antigen (HBsAg),
anti-hepatitis B core antibodies (anti-HBc Ab) if compound having possible immune
activities, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency
virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- Positive result on urine drug screen (amphetamines/ methamphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates).
- Participant who has results of laboratory tests which are outside the normal range or
hemoglobin (Hb) or red blood cells (RBC) indices (mean corpuscular volume [MCV], mean
corpuscular hemoglobin [MCH] and mean corpuscular hemoglobin concentration [MCHC])
with deviation outside 5% of the reference range at screening. (Laboratory tests are
performed not longer than two weeks before the initiation of the clinical study).
- Participants who have been on a specific/special diet during the 4 weeks before
screening and who cannot agree to eat the set clinical food menu during the study.
- Difficulty in swallowing tablets.
- Participants that have a current active Coronavirus disease 2019 (COVID-19) infection,
either laboratory confirmed or according to the investigator's medical judgement.
- Participants known to be in contact with active COVID-19 positive individuals within
the past 14 days.
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