WithdrawnPhase 1ACTRN12621001446853

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.


Sponsor

Zenith Technology Corporation Limited

Enrollment

24 participants

Start Date

Nov 1, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria6

  • 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 Criteria8

  • 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

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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 tria

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.


Locations(1)

Otago, New Zealand

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ACTRN12621001446853