PainPhase 1NCT05022810
A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects
A Phase 1 study testing New Paracetamol Oral Suspension (24 mg/ml) and Panadol B&I Oral Suspension (24 mg/ml paracetamol) in people with Pain, run by HALEON at 1 site in Czechia.
Trial summary
The objective of the study is to compare the bioequivalence of a New Paracetamol Oral Suspension 24 milligram/milliliter (mg/ml) with that of an already approved Paracetamol (24 mg/ml) Oral Suspension (Panadol Baby \& Infant) when administered to healthy volunteers under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- New Paracetamol Oral Suspension (24 mg/ml) and Panadol B&I Oral Suspension (24 mg/ml paracetamol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Aug 2021to 8 Sep 2021
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- A participant with a Body Mass Index (BMI) of 18.5 to 30.0 kg/m^2; and a total body weight >50 kg
- Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 7 days after the last dose of assigned treatment.
- Participant with two consecutive negative tests for active COVID-19, separated by > 24 hours.
- Czech citizenship
Who cannot join
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSKCH employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days before dosing.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is pregnant as confirmed by a positive hCG laboratory test or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. This includes paracetamol and excipients in the products e.g. sorbitol, maltitol glycerol etc.
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- A participant unwilling or unable to comply with Lifestyle Considerations.
- Diagnosis of long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
- A participant with evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance but not limited to any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, e.g., appendectomy and herniorrhaphy)
- History of inflammatory bowel disease
- History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine (≥ 123 μmol/l) or urea (≥ 8.9 mmol/L) or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria);
- History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1) AST/SGOT (≥ 1.2 ULN), ALT/SGPT (≥ 1.2 ULN), 2) GGT (≥ 1.2 ULN), ALP (≥ 1.2 ULN), 3) bilirubin (≥ 1.2 ULN) or CK (≥ 3 ULN). A single deviation from the above values is acceptable and will not exclude the candidate, unless specifically advised by the Investigator;
- Evidence of urinary obstruction or difficulty in voiding at screening.
- History or clinical evidence at screening of pancreatic injury or pancreatitis
- A participant with history of regular alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, i.e. 1 drink/day for women or 2 drinks/day for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening
- Participant reported regular consumption of > 5 cups of coffee or tea per day (or equivalent consumption of ≥ 500 mg xanthine per day using other products)
- Positive results in any of the virology tests for HIV-Ab, HCV-Ab, HBsAg and HBc-Ab (IgG + IgM)
- Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the Investigator's opinion may pose a risk to the candidate.
- Any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk
- A participant who has previously been enrolled in this study.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study
- Use of any medication (including over-the-counter medications, vitamins, herbal remedies, dietary supplements) within 2 weeks prior to admission to the unit or within less than 10 times the elimination half-life of the respective drug (whichever is longer) or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
- systemic contraceptives and hormone replacement therapy, as long as female participant is on stable treatment for at least 3 months and continues treatment throughout the study;
- occasional use of ibuprofen 200 mg (up to 1200 mg daily) or equivalent analgesic
- Participant reports consumption of any drug metabolizing enzyme (e.g. CYP3A4 or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages or food supplements (e.g. broccoli, Brussels sprouts, grapefruit, grapefruit juice, star fruit, St. John's Wort etc.) within 2 weeks prior to admission to the unit
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
- Body temperature is consistently out of the range of 35.4-37.3°C at screening, at check-in or during the study.
- Clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to screening till admission to the unit
- A participant with a positive urine drug screen, alcohol breath test at screening and on day of admission to the unit
- Smokers, defined as the use of tobacco products during the 3 months prior to screening till admission to the unit or a positive urine cotinine test at screening
- Performance of strenuous physical exercise (body building, high performance sports) from 2 weeks prior to admission to the unit
- Donation or loss of at least 500 mL of blood within 90 days or any donation of plasma or platelets from 2 weeks prior to admission to the unit
- Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before the screening till admission to the unit, unless evaluated by Investigator as non-significant for inclusion in the study
- Participant with signs and symptoms suggestive of COVID-19 (i.e. fever, cough, etc.) from 2 weeks prior to screening till admission to the unit
- Participant with known COVID-19 positive contacts in the past from 2 weeks prior to screening till admission to the unit
- Participants who were hospitalized for COVID-19 related reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Center, Single Dose, Two Period, Two Sequence, Crossover Bioequivalence Study of Paracetamol in a New Pediatric Paracetamol Oral Suspension Compared to a Marketed Paracetamol Oral Suspension (Panadol Baby & Infant) in Healthy Adult Subjects
The objective of the study is to compare the bioequivalence of a New Paracetamol Oral Suspension 24 milligram/milliliter (mg/ml) with that of an already approved Paracetamol (24 mg/ml) Oral Suspension (Panadol Baby \& Infant) when administered to healthy volunteers under fasting condition. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
Read the detailed description
This will be a 2-arm, single center, single dose, open-label, randomized, two-sequence, two period crossover, bioequivalence study in healthy adult participants. Participants will be screened for eligibility within 15 days prior to dosing. Participants will receive each of the two study treatments in fasted state during a 6-day (5-overnight stay) residential period at the study site. Participants will receive both treatment regimens in a randomized order with a 72-hour washout period between each dose. During each treatment period, a total of 21 blood samples will be collected which will include a pre-dose blood sample 1 hour before dosing and 20 post-dose blood samples at 5, 10, 20, 30, 40, 50, 60, 80, 90, 120, 150, 180 minutes, 4, 5, 6, 8, 10, 12, 14, 16 hours, for bioanalytical analyses of paracetamol.
- Conditions
- Pain
- Being tested
- New Paracetamol Oral Suspension (24 mg/ml), Panadol B&I Oral Suspension (24 mg/ml paracetamol)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Paracetamol Oral Suspension (24 mg/ml)Drug
After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
Panadol B&I Oral Suspension (24 mg/ml paracetamol)Drug
After an overnight fasting for at least 10 hours, Panadol B\&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period. Receives: Drug: New Paracetamol Oral Suspension (24 mg/ml) |
| Reference Drug | Active comparator | Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period Receives: Drug: Panadol B&I Oral Suspension (24 mg/ml paracetamol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast])
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
The Time of the Maximum Observed Post-dose Concentration (Tmax)
Blood samples were collected at the indicated time points for for the analysis of tmax. PK parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
The Maximum Observed Post-dose Concentration (Cmax)
Blood samples were collected at the indicated time points for for the analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Secondary outcomes (3)
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)]
AUC (0-inf) = AUC (0-tlast) + Clast/ λz, where Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Blood samples were collected at the indicated time points for for the analysis of AUC (0-inf). PK parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex)
%AUCex = (1- [AUC0-tlast/AUC0-inf]*100). Blood samples were collected at the indicated time points for for the analysis of %AUCex. PK parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Terminal Elimination Rate Constant (λz)
λz is computed as the slope of the regression line of ln (concentration) verses time. Blood samples were collected at the indicated time points for for the analysis of λz. PK parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post Dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start23 Aug 2021
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
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 PainStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- 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
- Model description
- This is a 2-arm, single center, single dose, open-label, randomized, two sequence, two-period crossover, bioequivalence study in healthy adult subjects, separated by one wash-out period of at least 72 hours.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022810
- Sponsor's protocol ID
- 215262
- Other IDs
- 2021-000900-40
- Status last verified
- Jul 2023
- First submitted
- 20 Aug 2021
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Center, Single Dose, Two Period, Two Sequence, Crossover Bioequivalence Study of Paracetamol in a New Pediatric Paracetamol Oral Suspension Compared to a Marketed Paracetamol Oral Suspension (Panadol Baby & Infant) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05022810
- Acronym / sponsor ID
- 215262
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the bioequivalence of a New Paracetamol Oral Suspension 24 milligram/milliliter (mg/ml) with that of an already approved Paracetamol (24 mg/ml) Oral Suspension (Panadol Baby \& Infant) when administered to healthy volunteers under fasting condition. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
Detailed description
This will be a 2-arm, single center, single dose, open-label, randomized, two-sequence, two period crossover, bioequivalence study in healthy adult participants. Participants will be screened for eligibility within 15 days prior to dosing. Participants will receive each of the two study treatments in fasted state during a 6-day (5-overnight stay) residential period at the study site. Participants will receive both treatment regimens in a randomized order with a 72-hour washout period between each dose. During each treatment period, a total of 21 blood samples will be collected which will include a pre-dose blood sample 1 hour before dosing and 20 post-dose blood samples at 5, 10, 20, 30, 40, 50, 60, 80, 90, 120, 150, 180 minutes, 4, 5, 6, 8, 10, 12, 14, 16 hours, for bioanalytical analyses of paracetamol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 2-arm, single center, single dose, open-label, randomized, two sequence, two-period crossover, bioequivalence study in healthy adult subjects, separated by one wash-out period of at least 72 hours.
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: New Paracetamol Oral Suspension (24 mg/ml)Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period. |
| Reference Drug | Active comparator | Drug: Panadol B&I Oral Suspension (24 mg/ml paracetamol)Participants will receive a single oral dose of either New Paracetamol Oral Suspension (24 mg/ml) or Panadol B\&I Oral Suspension (24 mg/ml paracetamol) on Day 1 (Period 1) and Day 4 (Period 2) under fasting conditions as per the randomization schedule. A wash out period of at least 72-hour will be maintained between each treatment period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- A participant with a Body Mass Index (BMI) of 18.5 to 30.0 kg/m^2; and a total body weight >50 kg
- Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 7 days after the last dose of assigned treatment.
Key exclusion criteria (38 listed)
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSKCH employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days before dosing.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who is pregnant as confirmed by a positive hCG laboratory test or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
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 |
|---|---|---|
| New Paracetamol Oral Suspension (24 mg/ml)After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period. | Drug | Test Drug |
| Panadol B&I Oral Suspension (24 mg/ml paracetamol)After an overnight fasting for at least 10 hours, Panadol B\&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period. | Drug | Reference Drug |
Primary outcome
The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast])
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
The Time of the Maximum Observed Post-dose Concentration (Tmax)
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Blood samples were collected at the indicated time points for for the analysis of tmax. PK parameters were calculated by standard non-compartmental analysis.
The Maximum Observed Post-dose Concentration (Cmax)
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Blood samples were collected at the indicated time points for for the analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
3 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)]
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex)
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
Terminal Elimination Rate Constant (λz)
Time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post Dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing New Paracetamol Oral Suspension (24 mg/ml) and Panadol B&I Oral Suspension (24 mg/ml paracetamol) in people with Pain, run by HALEON at 1 site in Czechia.
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 38 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Feb 2024). 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?
The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast]) (time frame: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.