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Comparative assessment of the absorption of a generic formulation of a combination N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension against two innovator formulations administered simultaneously of N-(4-hydroxyphenyl)acetamide oral suspension and (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.

A single dose, randomized, open label bioequivalence study of a generic formulation of 10ml of a combination 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension in a 2 way crossover comparison against two innovator formulations administered simultaneously of 5 ml of 250 mg of N-(4-hydroxyphenyl)acetamide oral suspension and 5 ml of 100 mg of (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension conducted under fasting conditions in healthy volunteers.

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001446853
Enrollment
24
Registered
2021-10-25
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-09-12

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

Conditions

None listed

Brief summary

The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of the reference formulations, following oral administration of a single 10 ml dose of 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid to healthy male and female subjects under fasting conditions.

Interventions

The combination test formulation of 1 x 10 ml of 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension on one occasion. The intervention for this trial is the test oral suspension formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visit

The combination test formulation of 1 x 10 ml of 250/100 mg N-(4-hydroxyphenyl)acetamide/(RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid oral suspension on one occasion. The intervention for this trial is the test oral suspension formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 14 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. The standard meals will be consumed 4 hours and 9 hours after dosing (at approximately 12pm and 5pm). Alcohol breath testing and dipstick drugs of abuse tests will be performed upon each participant reporting to the clinical site 12 hours prior to dosing. Screening and study exit laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must swallow the entire suspension and a mouth check will be conducted to ensure that the medication has been taken as directed.

Sponsors

Zenith Technology Corporation Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Healthy males and females Aged between 18 and 55 Non-smoker BMI between 18 and 33 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent

Exclusion criteria

Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches Concomitant drug therapy of any kind Sensitivity to any of the medicines or ingredients History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Smoker (anyone who has smoked in the last 6 months) History of alcohol or drug abuse or dependency Participation in a drug study within 60 days of the start of the study or donated blood in the 30 days preceding the study. Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026