Comparative assessment of the absorption of a generic formulation of tamsulosin tablet against the innovator tamsulosin tablet conducted under fasting condition and at steady state in healthy male and female volunteers.
A multiple 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 fasting conditions and at steady state in healthy male and female volunteers.
Zenith Technology Corporation Limited
24 participants
Jul 17, 2018
Interventional
Conditions
Summary
The objective of this study is to evaluate the bioequivalence of the test formulation relative to that of a reference formulation, following oral administration of multiple doses of 0.4 mg tamsulosin tablet to healthy male and female subjects under fasting 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
Multiple dose, crossover study design whereby each participant receives the test formulation of 0.4 mg tamsulosin tablet on five occasions and the innovator formulation of 0.4 mg tamsulosin tablet on five occasions with each dose separated by a 10 day washout period. The intervention for this trial is the test tablet formulation. On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test). 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 4 hours before receiving each dose on study days 1 to 5 and 15 to 19. On study days 5 and 19 subjects will report to the Zenith Clinical Site for dosing and observation of adverse events and the provision of one blood sample. They are required to stay at the clinical site for 24 hours after dosing. On study days 1 to 4 and 15 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample. On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and subjects are required to fast for 8 hours prior to receiving the dose and 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 8 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing. Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 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.
Locations(1)
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ACTRN12618001147279