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A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non-Dependent Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01825447
Enrollment
89
Registered
2013-04-05
Start date
2013-07-31
Completion date
2013-09-30
Last updated
2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

abuse potential, abuse liability, drug liking, oxycodone, naltrexone, intravenous, pharmacodynamic

Brief summary

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

Interventions

DRUGPlacebo

0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.

DRUGOxycodone + Naltrexone

Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.

DRUGOxycodone

Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.

Sponsors

Lifetree Clinical Research Center, Salt Lake City, Utah
CollaboratorUNKNOWN
Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects * Non-dependent, recreational opioid users * Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion criteria

* Diagnosis of substance and/or alcohol dependence * Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder * History of sleep apnea.

Design outcomes

Primary

MeasureTime frameDescription
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-doseDrug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Drug Liking: Peak Effect (Emax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
High: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-doseHigh VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
High: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—

Secondary

MeasureTime frameDescription
High: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-doseHigh VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
High: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Take Drug Again: Peak Effect (Emax)12, 24 h post-doseTake Drug Again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100-point bipolar VAS with score ranging from 0 mm to 100 (score of 0 =
Take Drug Again: Mean Effect (Emean)12, 24 h post-dose—
Overall Drug Liking: Peak Effect (Emax)12, 24 h post-doseOverall Drug Liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100-point VAS is used to assess response based on a score ranging from 0 to 100 (0 =
Overall Drug Liking: Mean Effect (Emean)12, 24 h post-dose—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour5 min, 15 min, 30 min, 45 min, 1 h post-doseAny Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Any Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Any Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour5 min, 15 min, 30 min, 45 min, 1 h post-doseGood Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h—
Good Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour5 min, 15 min, 30 min, 45 min, 1 h post-doseBad Drug Effects VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h—
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-8 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-doseFeel Sick VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Nausea: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-doseNausea VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Nausea: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Nausea: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Good Drug Effects: Peak Effect (Emax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Bad Drug Effects: Peak Effect (Emax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-doseSleepy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-doseDizzy VAS assesses the effect experienced by the participant on a 100-point unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0) to 'extremely' (score of 100).
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Feel Sick: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Nausea: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Sleepy: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Dizzy: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hourpre-dose, 5 min, 15 min, 30 min, 45 min, 1 h post-dosePupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants have the size of their pupil measured (in mm) using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2 h post-dose—
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Pupillometry: Peak Effect (Emax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Pupillometry: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Drug Liking: Time to Maximum (Peak) Effect (TEmax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
High: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Sleepy: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Dizzy: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Nausea: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Feel Sick: Time to Maximum (Peak) Effect (TEmax)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Plasma Concentration of Oxycodone 5 Minutes Post-Dose (C5min)pre-dose, 5 min post-dose—
Plasma Concentration of Oxymorphone 5 Minutes Post-Dose (C5min)pre-dose, 5 min post-dose—
Plasma Concentration of Noroxycodone 5 Minutes Post-Dose (C5min)pre-dose, 5 min post-dose—
Plasma Concentration of Naltrexone 5 Minutes Post-Dose (C5min)pre-dose, 5 min post-dose—
Plasma Concentration of 6-beta-naltrexol 5 Minutes Post-Dose (C5min)pre-dose, 5 min post-dose—
Plasma Decay Half-Life (t1/2) of Oxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dosePlasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-Life (t1/2) of Oxymorphonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Plasma Decay Half-Life (t1/2) of Noroxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Plasma Decay Half-Life (t1/2) of Naltrexonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Plasma Decay Half-Life (t1/2) of 6-beta-naltrexolpre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Oxycodone Concentration-Time Curve (AUC0-1h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-doseAUC is a measure of the plasma concentration of the drug over time.
Area Under the Oxymorphone Concentration-Time Curve (AUC0-1h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Noroxycodone Concentration-Time Curve (AUC0-1h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Naltrexone Concentration-Time Curve (AUC0-1h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-1h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Oxycodone Concentration-Time Curve (AUC0-2h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Oxymorphone Concentration-Time Curve (AUC0-2h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Noroxycodone Concentration-Time Curve (AUC0-2h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Naltrexone Concentration-Time Curve (AUC0-2h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-2h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Oxycodone Concentration-Time Curve (AUC0-8h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Oxymorphone Concentration-Time Curve (AUC0-8h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Noroxycodone Concentration-Time Curve (AUC0-8h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Naltrexone Concentration-Time Curve (AUC0-8h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the 6-beta-naltrexol Concentration-Time Curve (AUC0-8h)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero to Last Quantifiable Oxycodone Concentration (AUClast)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero to Last Quantifiable Oxymorphone Concentration (AUClast)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero to Last Quantifiable Noroxycodone Concentration (AUClast)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero to Last Quantifiable Naltrexone Concentration (AUClast)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero to Last Quantifiable 6-beta-naltrexol Concentration (AUClast)pre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Oxymorphonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Noroxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for Naltrexonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf) for 6-beta-naltrexolpre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Systemic Clearance (Cl) of Oxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-doseCL is a quantitative measure of the rate at which a drug substance is removed from the body.
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hourspre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—
Systemic Clearance (Cl) of Noroxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Systemic Clearance (Cl) of Naltrexonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Systemic Clearance (Cl) of 6-beta-naltrexolpre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Volume of Distribution at Steady State (Vss) for Oxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-doseVolume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Volume of Distribution at Steady State (Vss) for Oxymorphonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Volume of Distribution at Steady State (Vss) for Noroxycodonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Volume of Distribution at Steady State (Vss) for Naltrexonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Volume of Distribution at Steady State (Vss) for 6-beta-naltrexolpre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Systemic Clearance (Cl) of Oxymorphonepre-dose, 5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Any Drug Effects: Peak Effect (Emax)5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose—
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour5 min, 15 min, 30 min, 45 min, 1 h post-doseDrug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100-point bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours5 min, 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8 h post-dose—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026