HealthyPhase 1NCT02465866

A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

A Phase 1 study testing CL-108, Vicoprofen and Ultracet in people with Healthy, run by Charleston Laboratories, Inc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CL-108, Vicoprofen and Ultracet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: Nov 2014to Apr 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Written informed consent
Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
Abide by study restrictions
Acceptable birth control measures
Ability to attend all study visits
Vital signs as per protocol
Willing to consume high calorie meals within designated time frame

Who cannot join

Clinically significant medical history
Clinically significant abnormal findings
History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
Has smoked or used tobacco products within 60 days prior to the first dose of study medication
Has donated blood or plasma within 30 days prior to the first dose of study medication
Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.

About this study

Official title: A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.

Conditions: Healthy
Being tested: CL-108, Vicoprofen, Ultracet, Phenergan
Keywords: Plasma concentration, Time to plasma concentration, Elimination rate constant, Elimination half life, Area under the curve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CL-108Drug
Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
VicoprofenDrug
Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
UltracetDrug
Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
PhenerganDrug
Also called Promethazine HCl
Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth

Study groups in NCT02465866
Study group	Role	What they receive
Treatment A: CL-108 (Fasted)	Experimental	CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Receives: Drug: CL-108
Treatment B: CL-108 (Fed)	Experimental	CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Receives: Drug: CL-108
Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)	Active comparator	Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Receives: Drug: Vicoprofen; Drug: Ultracet; Drug: Phenergan
Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)	Active comparator	Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition Receives: Drug: Vicoprofen; Drug: Ultracet; Drug: Phenergan

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Time of the Last Quantifiable Concentration (Tlast)
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Observed Elimination Rate Constant (λz)
Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Observed Terminal Elimination Half-life (T1/2)
Calculated as: T1/2 = ln(2)/λz
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 0.25 hours post-dose
AUC0-0.50 for Hydrocodone and Promethazine
AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 0.5 hours post-dose
AUC0-0.75 for Hydrocodone and Promethazine
AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (Pre-dose) to 0.75 hours post-dose
AUC0-1.0 for Hydrocodone and Promethazine
AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 1.0 hours post-dose
AUC0-1.5 for Hydrocodone and Promethazine
AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 1.5 hours post-dose
AUC0-2.0 for Hydrocodone and Promethazine
AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 2 hours post-dose
AUC0-4.0 for Hydrocodone and Promethazine
AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
Measured: 0 (pre-dose) to 4 hours post-dose
Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
Calculated using the linear trapezoidal rule
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
Calculated as:
AUCinf = AUClast + Clast/λz
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
Calculated as:
AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Apr 2015

First posted9 Jun 2015 (estimated)
Study startNov 2014
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465866
Sponsor's protocol ID: CLCT-004
Status last verified: Mar 2017
First submitted: 4 Jun 2015
Last updated: 2 May 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
ClinicalTrials.gov ID: NCT02465866
Acronym / sponsor ID: CLCT-004
Conditions: Healthy
Keywords: Plasma concentration, Time to plasma concentration, Elimination rate constant, Elimination half life, Area under the curve
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Charleston Laboratories, IncIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 9 Jun 2015 (estimated)
Results: Posted 20 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A: CL-108 (Fasted)	Experimental	Drug: CL-108CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
Treatment B: CL-108 (Fed)	Experimental	Drug: CL-108CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)	Active comparator	Drug: Vicoprofen, Drug: Ultracet, Drug: PhenerganVicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)	Active comparator	Drug: Vicoprofen, Drug: Ultracet, Drug: PhenerganVicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Written informed consent
Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
Abide by study restrictions
Acceptable birth control measures
Ability to attend all study visits

Key exclusion criteria (6 listed)

Clinically significant medical history
Clinically significant abnormal findings
History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
Has smoked or used tobacco products within 60 days prior to the first dose of study medication
Has donated blood or plasma within 30 days prior to the first dose of study medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CL-108Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth	Drug	Treatment A: CL-108 (Fasted), Treatment B: CL-108 (Fed)
VicoprofenHydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth	Drug	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted), Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
UltracetTramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth	Drug	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted), Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
PhenerganAlso: Promethazine HClPhenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth	Drug	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted), Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)

Primary outcome

Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.
Time to Reach Maximum Concentration (Tmax)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Time of the Last Quantifiable Concentration (Tlast)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Observed Elimination Rate Constant (λz)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
Observed Terminal Elimination Half-life (T1/2)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Calculated as: T1/2 = ln(2)/λz
Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 0.25 hours post-dose
AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-0.50 for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 0.5 hours post-dose
AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-0.75 for Hydrocodone and Promethazine
Time frame: 0 (Pre-dose) to 0.75 hours post-dose
AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-1.0 for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 1.0 hours post-dose
AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-1.5 for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 1.5 hours post-dose
AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-2.0 for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 2 hours post-dose
AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-4.0 for Hydrocodone and Promethazine
Time frame: 0 (pre-dose) to 4 hours post-dose
AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Calculated using the linear trapezoidal rule
Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Calculated as: AUCinf = AUClast + Clast/λz
Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Calculated as: AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100

Results and safety

Results posted to the registry on 20 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: ABDC	5	5
Sequence 2: BCAD	5	5
Sequence 3: CDBA	5	5
Sequence 4: DACB	5	5

Primary outcome: Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A: CL-108 (Fasted) n = 19	Treatment B: CL-108 (Fed) n = 20	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) n = 20	Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) n = 19
Hydrocodone	20.0 (5.48)	17.9 (5.80)	18.4 (5.62)	17.5 (3.63)
Acetaminophen	4.71 (1.49)	3.27 (1.00)	5.02 (1.66)	3.03 (0.919)
Promethazine (Number of Participants=19,19,20,19)	4.79 (3.75)	3.66 (2.16)	4.35 (2.94)	4.08 (1.95)

Population analysed: Intended to treat (ITT) population

Primary outcome: Time to Reach Maximum Concentration (Tmax)

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	Treatment A: CL-108 (Fasted) n = 19	Treatment B: CL-108 (Fed) n = 20	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) n = 20	Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) n = 19
Hydrocodone	1.55 (0.71)	3.38 (1.58)	1.39 (1.22)	3.09 (1.89)
Acetaminophen	0.91 (0.44)	2.84 (1.49)	0.80 (0.55)	2.64 (1.44)
Promethazine (Number of Participants=19,19,20,19)	4.35 (1.37)	5.24 (2.37)	4.90 (1.72)	6.45 (4.59)

Population analysed: ITT population

Primary outcome: Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A: CL-108 (Fasted) n = 19	Treatment B: CL-108 (Fed) n = 20	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) n = 20	Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) n = 19
Hydrocodone	0.556 (0.354)	0.523 (0.412)	0.465 (0.315)	0.527 (0.424)
Acetaminophen	0.0741 (0.0297)	0.0917 (0.0378)	0.0724 (0.0291)	0.0907 (0.0428)
Promethazine (Number of Participants=19,19,20,19)	0.611 (0.936)	0.586 (1.04)	0.574 (0.829)	0.701 (0.912)

Population analysed: ITT population

Primary outcome: Time of the Last Quantifiable Concentration (Tlast)

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose. Mean (Standard Deviation). Unit: Hours

Measure	Treatment A: CL-108 (Fasted) n = 19	Treatment B: CL-108 (Fed) n = 20	Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) n = 20	Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) n = 19
Hydrocodone	27.80 (8.99)	31.21 (11.28)	28.81 (9.84)	31.58 (11.46)
Acetaminophen	23.38 (2.76)	24.01 (0.04)	23.41 (2.69)	24.01 (0.02)
Promethazine (Number of Participants=19,19,20,19)	46.76 (5.51)	46.77 (5.52)	46.81 (5.37)	46.74 (5.51)

Population analysed: ITT population

Adverse events

Time frame: Up to day 72. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: CL-108 (Fasted)	0 of 19 (0%)	3 of 19 (15.8%)	Not reported
Treatment B: CL-108 (Fed)	0 of 20 (0%)	11 of 20 (55%)	Not reported
Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)	0 of 20 (0%)	20 of 20 (100%)	Not reported
Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)	0 of 19 (0%)	2 of 19 (10.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CL-108, Vicoprofen and Ultracet in people with Healthy, run by Charleston Laboratories, Inc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data (time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.