Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State
BET04cap
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover study with a seven-days washout interval was conduced in 32 healthy male volunteers. The plasma samples were obtained up to 72 hours after drug administration. A sensitive and specific LC-MS/MS method was developed and validated for the determination of tansulosine in human plasma. Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 3, 2011
April 1, 2011
Same day
April 18, 2011
May 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence interval
Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.
3 months
Study Arms (1)
Tansulosine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- They were within 10% of their ideal body weight.
- Biochemical test and physical examination were carried out.
- No concomitant medications were allowed.
- Volunteers did not drink caffeine-containing drinks 48-hours before the study.
- The volunteers gave written informed consent to participate in the study.
You may not qualify if:
- Chronic disease
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocineselead
Study Sites (1)
Biocinese
Toledo, Paraná, 85903-590, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josélia Manfio, Dr
Biocinese
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 18, 2011
First Posted
April 19, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
May 3, 2011
Record last verified: 2011-04