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

NCT05022810 | Completed Phase 1 Results

• 2 other identifiers: 2152622021-000900-40
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)]

  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)

  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)

  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.

Study Arms (2)

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.

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

Drug: Panadol B&I Oral Suspension (24 mg/ml paracetamol)

Interventions

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.

Test Drug

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.

Reference Drug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Prague, 102 00, Czechia

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Marc Renard
• Organization: HALEON

marc.m.renard@haleon.com

+44 7880 182593

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: August 23, 2021
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CZ (1)