Age: 18 - 45
Healthy Volunteers: Accepted
Inclusion Criteria:
1. Be a male or female, 18-45 years of age, able and willing to provide written informed consent to participate in the trial.
2. Be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
3. Have body mass index (BMI) of 19-35 kg/m\^2.
4. (Healthy Volunteer participants only): Willing to remain in confinement at the clinical trial unit for 1.5 consecutive days (one night) and to return to the unit at 7±2 days for a final AE assessment and additional blood tests and safety evaluations.
5. (Dental Pain participants only): Planned extraction of three (3) third molars with at least two of which are ≥50% impacted mandibular molars.
6. Have normal blood pressure (BP) \[systolic BP = 90-140 mmHg, diastolic BP = 45-90 mmHg\] and heart rate (HR) \[resting HR = 45-100 beats per minute (bpm) without medication.
7. Have normal O2 saturation levels (95% to 100%).
8. Have normal laboratory parameters values within the normal range or considered non-clinically significant by the Investigator.
9. All women need to have a negative urine pregnancy test at screening. On the morning of dosing or surgery, women of childbearing potential must have a negative pregnancy test.
10. Have a negative urine drug test (UDT) at screening.
11. Non-smoker.
12. Be able to read and communicate meaningfully in English and comply with all trial procedures.
13. Be willing to voluntarily sign an informed consent form (ICF), prior to the conduct of any trial-specific procedures.
14. Male participants and their female sexual partners must agree to use double barrier contraception during the trial period and for 2 months afterward, or provide proof of surgical sterility, or abstain from heterosexual coital sexual activity (heterosexual abstinence is considered to be a highly effective method only if the participant agrees to refrain from heterosexual intercourse during the entire period from 30 days prior to screening to 90 days after the last trial drug administration).
15. Female participant will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year or surgically sterile for at least 3 months, or will agree to use double-barrier contraception for 28 days and/or from their last confirmed menstrual period prior to trial enrollment (whichever is longer) until 2 months after Clinic Discharge.
Exclusion Criteria:
1. Participants taking any type of medication on a regular basis will be excluded from participation in the trial (females will be allowed to continue using oral contraceptives).
2. Using any pain medication on a regular schedule; participants taking pain medication occasionally as needed will be allowed in the trial as long as they agree to discontinue all pain medication for at least 24 hours (or 5 half-lives, whichever is longer) before surgery and during the trial.
3. Using centrally acting substances during or for up to 14 days prior to entering the trial (i.e., hypnotics, sedatives, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, first generation antihistamines and sympathomimetic amines).
4. Have a history of drug abuse or any positive findings in UDT.
5. Have a history of an upper gastrointestinal (GI) disorder within 6 months of screening.
6. Have contraindications to trial medication (opioids, nonsteroidal anti-inflammatory drug \[NSAIDs\]).
7. Bleeding disorder, dysphagia, serious complications after molar extraction, or chronic hepatic, renal, or GI disease.
8. Have been administered a systemic corticosteroid within 1 month prior to surgery (inhaled or topical steroids are allowed).
9. Have a history of congestive heart failure.
10. Have a family history of significant cardiac disease (i.e. sudden death in first degree relative; myocardial infarction prior to 50 years old).
11. Have a history of seizures or any type of seizure disorder.
12. Have a history of cognitive or psychiatric disorders or any other condition that could interfere with compliance with trial procedures.
13. Have a history of drug or alcohol abuse within one year prior to screening.
14. Use of any other investigational drug within 1 month prior to enrollment.
15. Donation and/or receipt of any blood or blood product within 1 month prior to enrollment.
16. Have, in the judgment of the Investigator, a condition that would pose a risk to the participant, interfere with the participant's ability to complete the trial, or confound the trial results.