Trial Outcomes & Findings for Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions (NCT NCT01149733)
NCT ID: NCT01149733
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood samples drawn over 60 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Tamsulosin
0.4 mg Capsule
|
Flomax®
0.4 mg Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Tamsulosin
n=16 Participants
0.4 mg Capsule
|
Flomax®
n=16 Participants
0.4 mg Capsule
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples drawn over 60 hour periodBioequivalence based on Cmax
Outcome measures
| Measure |
Tamsulosin
n=16 Participants
0.4 mg Capsule
|
Flomax®
n=16 Participants
0.4 mg Capsule
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
8.8694 ng/mL
Standard Deviation 28
|
9.0150 ng/mL
Standard Deviation 26
|
PRIMARY outcome
Timeframe: Blood samples drawn over 60 hour periodBioequivalence based on AUC0-t
Outcome measures
| Measure |
Tamsulosin
n=16 Participants
0.4 mg Capsule
|
Flomax®
n=16 Participants
0.4 mg Capsule
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
137.0248 ng*h/mL
Standard Deviation 27
|
148.9023 ng*h/mL
Standard Deviation 28
|
PRIMARY outcome
Timeframe: Blood samples drawn over 60 hour periodBioequivalence based on AUC0-inf
Outcome measures
| Measure |
Tamsulosin
n=16 Participants
0.4 mg Capsule
|
Flomax®
n=16 Participants
0.4 mg Capsule
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
143.2749 ng*h/mL
Standard Deviation 29
|
157.9455 ng*h/mL
Standard Deviation 30
|
Adverse Events
Tamsulosin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flomax®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Director, Biopharmaceutics
Teva Pharmaceuticals USA
Phone: 866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER