Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants

This is a randomized (study medication assigned by chance), double-blind (neither physician
nor participant knows the treatment that the participant receives), 4-way crossover (method
used to switch participants from one treatment arm to another), placebo- and
positive-controlled (the experimental treatment or procedure is compared to an inactive
substance and a standard treatment or procedure), single site, multiple dose study. The study
has 3 phases: a Screening Phase (up to 35 days); a Double-blind Treatment Phase (4 treatment
periods with a washout period of 7 to 15 days); and a Post-treatment Phase (Day 5 of Period 4
or at the time of early withdrawal). All eligible participants will receive each of the 4
treatments: tramadol HCl at therapeutic dose of 400 milligram per day (mg/day), tramadol HCl
at supratherapeutic dose of 600 mg/day, placebo, and positive control moxifloxacin 400 mg; in
any of the treatment period as per assigned treatment sequence. The total duration of each
participant's participation will be up to a maximum of 100 days. Participants' safety will be
monitored throughout the study.

Inclusion Criteria:

- Woman participant of child-bearing potential, must have a negative serum beta-human
chorionic gonadotropin pregnancy test at Screening; and a negative urine pregnancy
test on Day 1 of each treatment period

- Standard electroencephalogram (EEG) that is normal, as assessed by a neurologist. The
EEG will be performed under basic conditions and during hyperventilation and
intermittent photic stimulation at Screening

- Body mass index (BMI; weight [in kilogram]/height [in square meter]) between 18 and 30
kilogram per square meter (inclusive), and body weight not less than 50 kilogram at
Screening

- Blood pressure between 90 and 140 millimeter of mercury (mm Hg) systolic (inclusive)
and no higher than 90 mm Hg diastolic

- An average of triplicate 12-lead electrocardiogram (ECG) recordings (performed in a
semi-supine position), completed within 4 minutes total, consistent with normal
cardiac conduction and function at Screening, including: 1- Sinus rhythm with heart
rate between 40 and 100 beats per minute (inclusive); 2- QTc interval between 350 to
450 milliseconds (inclusive); 3- QRS interval of less than 110 milliseconds; 4- PR
interval less than 200 milliseconds; 5- ECG morphology consistent with healthy cardiac
conduction and function

Exclusion Criteria:

- Personal or family history of epileptic seizures or convulsions (genetic or idiopathic
seizures), or have suffered from head trauma with loss of consciousness, central
nervous system infection, or loss of consciousness of unknown origin

- History of additional risk factors for torsades de pointes (TdP) or the presence of a
family history of short QT syndrome, long QT syndrome, sudden unexplained death at a
young age ( less than equal to 40 years), drowning or sudden infant death syndrome in
a first degree relative (that is, biological parent, sibling, or child)

- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at Screening or before the first dose of study drug on Day -1 of each
treatment period as assessed by the Investigator. Note that participants who have
serum potassium, magnesium, or calcium levels outside of the local laboratory's
reference range will be excluded

- Clinically significant abnormal physical examination or vital signs at Screening or
before the first dose of study drug on Day -1 of each treatment period as assessed by
the Investigator

- History of drug or alcohol abuse within 5 years before Screening or positive test
result(s) for alcohol or drugs of abuse (such as barbiturates, opiates, cocaine,
cannabinoids, amphetamines, hallucinogens, and benzodiazepines) at Screening or on Day
-1 of each treatment period