Trial Outcomes & Findings for SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin (NCT NCT01262989)
NCT ID: NCT01262989
Last Updated: 2017-08-14
Results Overview
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
COMPLETED
PHASE1
40 participants
Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)
2017-08-14
Participant Flow
Participant milestones
| Measure |
Test Product in Period 1; Reference Product in Period 2
Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
Reference Product in Period 1; Test Product in Period 2
Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
|---|---|---|
|
Period 1
STARTED
|
20
|
20
|
|
Period 1
COMPLETED
|
19
|
17
|
|
Period 1
NOT COMPLETED
|
1
|
3
|
|
7-Day Washout Period
STARTED
|
19
|
17
|
|
7-Day Washout Period
COMPLETED
|
19
|
17
|
|
7-Day Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
19
|
17
|
|
Period 2
COMPLETED
|
19
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test Product in Period 1; Reference Product in Period 2
Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
Reference Product in Period 1; Test Product in Period 2
Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
|---|---|---|
|
Period 1
Lost to Follow-up
|
1
|
1
|
|
Period 1
Intercurrent disease
|
0
|
1
|
|
Period 1
Positive answer for exclusion criteria
|
0
|
1
|
|
Period 2
Intercurrent disease
|
0
|
1
|
Baseline Characteristics
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
Baseline characteristics by cohort
| Measure |
Participants Receiving Both Test Product and Reference Product
n=40 Participants
Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
|
|---|---|
|
Age, Continuous
|
32.65 Years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mulatto
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)Population: Participants who completed the study
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
Outcome measures
| Measure |
Test Product
n=35 Participants
Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
Reference Product
n=35 Participants
Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
|---|---|---|
|
AUC0-t
|
237.35 ng per hour per ml (ng/h/ml)
Standard Deviation 115.56
|
226.74 ng per hour per ml (ng/h/ml)
Standard Deviation 103.34
|
PRIMARY outcome
Timeframe: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)Population: Participants who completed the study
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
Outcome measures
| Measure |
Test Product
n=35 Participants
Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
Reference Product
n=35 Participants
Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
|---|---|---|
|
AUC0-infinity
|
244.00 ng/h/ml
Standard Deviation 119.49
|
233.34 ng/h/ml
Standard Deviation 107.11
|
PRIMARY outcome
Timeframe: Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)Population: Participants who completed the study
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.
Outcome measures
| Measure |
Test Product
n=35 Participants
Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
Reference Product
n=35 Participants
Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
|
|---|---|---|
|
Cmax
|
20.27 ng/ml
Standard Deviation 9.54
|
20.80 ng/ml
Standard Deviation 7.86
|
Adverse Events
Test Product in Period 1; Reference Product in Period 2
Reference Product in Period 1; Test Product in Period 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product in Period 1; Reference Product in Period 2
n=20 participants at risk
Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
Reference Product in Period 1; Test Product in Period 2
n=20 participants at risk
Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
|
|---|---|---|
|
General disorders
Fever
|
0.00%
0/20
|
5.0%
1/20
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20
|
0.00%
0/20
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20
|
5.0%
1/20
|
|
Investigations
Serum glutamic-pyruvic increased
|
0.00%
0/20
|
20.0%
4/20
|
|
Investigations
Gamma glutamyl transferase increased
|
0.00%
0/20
|
20.0%
4/20
|
|
Investigations
Serum glutamic-oxaloacetic increased
|
0.00%
0/20
|
5.0%
1/20
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/20
|
5.0%
1/20
|
|
Investigations
Serum urea increased
|
0.00%
0/20
|
5.0%
1/20
|
|
Investigations
Blood urine present
|
0.00%
0/20
|
5.0%
1/20
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
Extremities burning sensation
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
35.0%
7/20
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/20
|
5.0%
1/20
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER