Comparative assessment of the absorption of a generic formulation of tamsulosin tablet against the innovator tamsulosin tablet conducted under fed condition in healthy male and female volunteers.
A single dose, randomized, blinded, bioequivalence study of a test formulation of tamsulosin tablet in a 2 way crossover comparison against the innovator tamsulosin tablet conducted under fed conditions in healthy male and female volunteers.
Zenith Technology Corp Ltd
28 participants
Jun 30, 2018
Interventional
Conditions
Summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to the that of a reference formulation, following oral administration of a combination single dose of 0.4 mg tamsulosin tablet to healthy male and female subjects under fed conditions.
Eligibility
Inclusion Criteria7
- Healthy males and non-pregnant female volunteers.
- Aged between 18 and 55
- Non-smoker
- BMI between 18.5 and 30
- Normal QTc for males and females
- Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- Able to provide written informed consent
Exclusion Criteria9
- Concomitant drug therapy of any kind
- Any history of orthostatic hypotension.
- Sensitive 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 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 within the 60 days preceding the study
- Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
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Interventions
Single dose, crossover study design whereby each participant receives the test formulation of 0.4 mg tamsulosin tablet on one occasion and the innovator formulation of 0.4 mg tamsulosin tablet on one occasion with each dose separated by a one 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 water consumed with the dose). Participants are required not to eat for 10 hours before receiving a standardised high fat content meal and to fast for approximately 4 hours after each dose. Bathroom visits 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. 0.4 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.
Locations(1)
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ACTRN12618001051235