Comparative assessment of the absorption of a generic formulation of alpha,alpha-dimethylphenethylamine tablet against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions in healthy male and female volunteers.

A single dose, randomized, blinded, bioequivalence study of a test formulation of alpha,alpha-dimethylphenethylamine tablet in a 2 way crossover comparison against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions in healthy male and female volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001303336

Enrollment

Registered

2017-09-11

Start date

2017-09-30

Completion date

2017-09-30

Last updated

2024-07-29

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 (new) tablet formulation relative to that of the capsule reference formulation following oral administration of a single dose of 40 mg alpha,alpha-dimethylphenethylamine to healthy male and female subjects under fasting conditions.

Interventions

Single dose, crossover study design whereby each participant receives the test formulation of alpha,alpha-dimethylphenethylamine oral tablet (1 x 40 mg) on one occasion and the innovator formulation of alpha,alpha-dimethylphenethylamine oral capsule (1 x 40 mg) on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test tablet formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours prior to dosing. Subjects are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose (1 x 40 mg) 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 the medication has been taken as directed.

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 male and non-pregnant females Aged between 18 and 55 Non-smoker BMI between 18 and 30 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 the study drug History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Females who are pregnant and/or are breastfeeding 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 60 days preceding the study. Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Outcome results