| Eligibility |
Inclusion Criteria:
- Participant must be 18 to 50 years of age inclusive, at the time of signing the
informed consent.
- 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 millimeters of mercury (mmHg) less than or equal to (<=)
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 microseconds (ms)<PR<220 ms, QRS<120 ms, 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 normal, 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 kilograms (kg) or more and body mass index (BMI) within the range
18.5 -30 kg per meter square (kg/m^2) (inclusive).
- Healthy Adult, male and female (woman of non-childbearing potential [WONCBP])
- 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 below: 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. b) Female
Participant is eligible to participate if she is a WONCBP. 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.
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular, 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 3 months.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or
asymptomatic postural hypotension defined as a decrease in SBP greater than or equal
to (>=)30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, participants with known hypersensitivity
to any component of the investigational medicinal product (IMP) formulation or
allergic disease diagnosed and treated by a physician. Participants who have
previously demonstrated hypersensitivity to hydrochlorothiazide or to any
sulfonamide-derived drugs.
- 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 grams (g) of alcohol: 12 ounces (360 milliliters [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
before first study drug administration.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen,
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).
- Participants with a history of allergy or bronchial asthma or systemic lupus
erythematosus.
- Participant who has results of laboratory tests which are outside the normal range or
hemoglobin (Hb) or red blood cell (RBC) indices (mean corpuscular volume [MCV], mean
corpuscular hemoglobin [MCH] and mean corpuscular hemoglobin concentration [MCHC])
with deviation outside 5% of the reference range. (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.
- 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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