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Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions in healthy male and female volunteers.

A single dose, randomized, blinded, pharmacokinetic study of a generic formulation of 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions in healthy volunteers.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000108718
Enrollment
28
Registered
2022-01-24
Start date
2022-03-25
Completion date
2022-03-25
Last updated
2022-05-23

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 N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet. In this study we will measure how much N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is absorbed into the bloodstream and compare the concentrations between the test and reference formulations.

Interventions

The intervention for this trial is the test formulation of 1 x 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet Each dose is separated by a one week washout period. 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 o

The intervention for this trial is the test formulation of 1 x 2 mg N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet Each dose is separated by a one week washout period. 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 24 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. Alcohol breath testing and urine dipstick drugs of abuse testing 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 be swallowed whole 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
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Healthy males and females Aged between 18 and 55 years Non-smoker BMI greater than or equal to 18 and less than 33 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Drug free as determined by urine drug testing Able to comply with the study restrictions Able to provide written informed consent

Exclusion criteria

Clinically significant medical conditions History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug History of alcohol or drug abuse or dependency Participation in a drug study within 30 days of the start of the study Sensitivities to the study drug or excipients Individuals 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