Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State (BET04cap)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 18, 2011 | ||||||||
| Last Updated Date | May 2, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Bioequivalence interval [ Time Frame: 3 months ] [ Designated as safety issue: No ] Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01338623 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State | ||||||||
| Official Title ICMJE | Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State | ||||||||
| 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. |
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| Detailed Description | The study protocol was approved by Local Ethics Committee (UNICAMP - Campinas, Brazil). The study was performed with 32 healthy male volunteers. They were within 10% of their ideal body weight. Biochemical test and physical examination were carried out. Their medical history was also obtained. . Volunteers did not drink caffeine-containing drinks 48-hours before the study. The volunteers gave written informed consent to participate in study. The study was designed as two-single-dose, randomized, open-label, balanced, crossover study, with two periods separated by 7-days washout. In both periods after a standard breakfast volunteers were given a single dose of their formulation (reference or test) of tansulosine with 200 mL of water. Blood samples (8 ml) were collected at 0 (pre-dose) and at 01:00; 02:00; 03:00; 04:00; 04;30; 05:00; 05:20; 05:40; 06:00; 06:20; 06:40; 07:00; 07:30; 08:00; 08:30; 09:00; 10:00; 12:00; 24:00; 48:00; 72:00h. These samples were centrifuged immediately and kept frozen at -20°C until the time of analysis. Standard meals were served at 4 and 8h after administration. During hospital confinement, volunteers were always under medical supervision. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Hyperplasia Prostatic | ||||||||
| Intervention ICMJE | Drug: Tansulosine
capsule 0,4 mg
Other Name: Omics |
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| Study Arm (s) | Experimental: Tansulosine
Intervention: Drug: Tansulosine |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||
| Estimated Completion Date | May 2011 | ||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01338623 | ||||||||
| Other Study ID Numbers ICMJE | P03/11 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Josélia Larger Manfio, Biocinese | ||||||||
| Study Sponsor ICMJE | Biocinese | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Biocinese | ||||||||
| Verification Date | April 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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