Healthy
Conditions
Brief summary
The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4 mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine facility, and the other is a batch, of equal size, produced at the Norman II facility
Interventions
DRUGFlomax®, Norman II facility
DRUGFlomax®, Nishine facility
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consents, as evidenced by signature on an Informed Consent Form approved by the investigational review board (IRB) following a full explanation of the nature and purpose of the study * Be a healthy male of any race between 18 and 40 years of age * Have a body weight within 10 % of normal for sex, height, and frame as specified by the Body Weight Nomogram for Inclusion/
Exclusion criteria
* Have no clinically significant abnormalities o the basis of medical history, physical examination, and vital signs with no significant orthostatic blood pressure change, which is defined as no more than a 20 mm Hg drop in systolic blood pressure on assuming and maintaining the standing position for 3 minutes after being supine for at least 5 minutes. There should be no clinically significant symptoms associated with the orthostatic blood pressure testing procedure * Have cardiovascular system that is within normal limits based on history, physical examination, and a 12-lead electrocardiogram (ECG) * Have a negative test for ethanol by breathalyzer * Have the ability to understand the requirements of the study, agree to abide by the study restrictions, and agree to return for the required assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma at different time points (AUC) | Up to 48 h after drug administration |
| Maximum concentration of the analyte in plasma (Cmax) | Up to 48 h after drug administration |
| Time to reach the maximum concentration of the analyte in plasma (tmax) | Up to 48 h after drug administration |
| Elimination half-life (t1/2) | Up to 48 h after drug administration |
| Terminal elimination rate constant of the analyte in plasma (λz) | Up to 48 h after drug administration |
| Number of participants with clinically relevant changes in laboratory values | Up to day 3 after last drug administration |
| Number of participants with clinically relevant changes in vital signs (heart rate, orthostatic blood pressure, weight, temperature, respiration rate) | Up to day 3 after last drug administration |
| Number of participants with adverse events | Up to day 3 after last drug administration |
| Number of participants with clinically relevant changes in ECG | Up to day 3 after last drug administration |
Outcome results
None listed