Trial Outcomes & Findings for Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male. (NCT NCT02417831)
NCT ID: NCT02417831
Last Updated: 2020-04-27
Results Overview
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Results posted on
2020-04-27
Participant Flow
Participant milestones
| Measure |
New MR (Test) / Registered MR (Reference)
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule followed by oral administration of tamsulosin registered 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days.
|
Registered MR (Reference) / New MR (Test)
Oral administration of tamsulosin registered 0.4mg MR capsule followed by oral administration of tamsulosin new 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days.
|
|---|---|---|
|
Period 1: Treatment Period 1 + Washout
STARTED
|
17
|
17
|
|
Period 1: Treatment Period 1 + Washout
COMPLETED
|
17
|
17
|
|
Period 1: Treatment Period 1 + Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2: Treatment Period 2 + Washout
STARTED
|
17
|
17
|
|
Period 2: Treatment Period 2 + Washout
COMPLETED
|
17
|
17
|
|
Period 2: Treatment Period 2 + Washout
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Baseline characteristics by cohort
| Measure |
All Subjects
n=34 Participants
Subjects each received two treatments which were each administered orally in the fasted state after an overnight fast of at least 10 hours. and separated by a washout period of 7 days. The treatments were:
* New MR (Test): Tamsulosin 0.4mg modified release (MR) capsule.
* Registered MR (Reference) : Tamsulosin 0.4mg capsule.
|
|---|---|
|
Age, Continuous
|
25.4 Years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: Pharmacokinetic set (PK set): All subjects who had evaluable pharmacokinetic (PK) data for both treatment periods were included in the statistical PK analysis for the study.
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
Cmax
|
21700 pg/mL
Geometric Coefficient of Variation 37.8
|
20520 pg/mL
Geometric Coefficient of Variation 36.7
|
PRIMARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: PK set
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
AUC0-tz
|
241500 h*pg/mL
Geometric Coefficient of Variation 48.4
|
238200 h*pg/mL
Geometric Coefficient of Variation 48.0
|
PRIMARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: PK set
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
(AUC0-inf)
|
248200 h*pg/mL
Geometric Coefficient of Variation 49.4
|
244700 h*pg/mL
Geometric Coefficient of Variation 48.9
|
SECONDARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: PK set
Time to maximum plasma concentration
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
Tmax
|
5.004 Hours
Interval 3.0 to 6.0
|
5.006 Hours
Interval 3.0 to 8.01
|
SECONDARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: PK set
Terminal elimination rate constant in plasma (λz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
λz
|
0.05 1/hours
Geometric Coefficient of Variation 28.40 • Interval 0.0338 to 0.133
|
0.05 1/hours
Geometric Coefficient of Variation 24.10 • Interval 0.0347 to 0.0766
|
SECONDARY outcome
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.Population: PK set
Apparent terminal elimination half-life of the analyte in plasma (t1/2) Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Outcome measures
| Measure |
New MR (Test)
n=34 Participants
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 Participants
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
t1/2
|
13.10 Hours
Geometric Coefficient of Variation 28.40 • Interval 5.22 to 20.5
|
13.52 Hours
Geometric Coefficient of Variation 24.10 • Interval 9.04 to 20.0
|
Adverse Events
New MR (Test)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Registered MR (Reference)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
New MR (Test)
n=34 participants at risk
Oral administration of tamsulosin new 0.4mg modified release (MR) capsule.
|
Registered MR (Reference)
n=34 participants at risk
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
14.7%
5/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
8.8%
3/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
1/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
5.9%
2/34 • From drug administration until 7days thereafter for each treatment arm, upto 10 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER