Trial Outcomes & Findings for Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male. (NCT NCT02417844)

NCT ID: NCT02417844

Last Updated: 2020-04-17

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 34 participants
• Primary outcome timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
• Results posted on: 2020-04-17

Participant Flow

Each treatment was administered after consumption of a high-fat, high-calorie breakfast.

Participant milestones

Measure	Tamsulosin HCl (Test) / Flomax Relief (Reference) Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule followed by oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).	Flomax Relief (Reference) / Tamsulosin HCl (Test) Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules) followed by oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

Baseline characteristics by cohort

Measure	All Subjects n=34 Participants Subjects each received two treatments which were each administered orally and separated by a washout period of 7 days. The treatments were: * Flomax Relief (Reference): Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules). * Tamsulosin hydrochloride (HCl) (Test): Tamsulosin HCl 0.4mg modified release (MR) capsule.
Age, Continuous	24.6 Years STANDARD_DEVIATION 5.53 • 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, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Population: Pharmacokinetic (PK) set which included all subjects who had evaluable PK data for both treatment periods.

Maximum measured concentration of analyte in plasma (Cmax)

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Maximum Measured Concentration (Cmax)	8826 pg/mL Geometric Coefficient of Variation 31.8	8856 pg/mL Geometric Coefficient of Variation 34.0

PRIMARY outcome

Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 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)

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)	164700 h*pg/mL Geometric Coefficient of Variation 42.4	165400 h*pg/mL Geometric Coefficient of Variation 43.7

PRIMARY outcome

Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 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).

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)	170100 h*pg/mL Geometric Coefficient of Variation 44.1	171000 h*pg/mL Geometric Coefficient of Variation 45.2

SECONDARY outcome

Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Population: PK set

Time from last dosing to the maximum plasma concentration (tmax).

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Time to Maximum Plasma Concentration (Tmax)	7.51 Hours Interval 4.0 to 12.01	8.00 Hours Interval 4.0 to 24.01

SECONDARY outcome

Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Population: PK set

Terminal elimination rate constant in plasma (λz)

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Terminal Elimination Rate Constant (λz)	0.05 1/hour Geometric Coefficient of Variation 21.6 • Interval 0.03 to 0.08	0.05 1/hour Geometric Coefficient of Variation 21.9 • Interval 0.04 to 0.1

SECONDARY outcome

Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 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)

Outcome measures

Measure	Tamsulosin HCl (Test) n=34 Participants Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 Participants Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsule).
Apparent Terminal Elimination Half-life (t1/2)	13.16 hours Geometric Coefficient of Variation 21.6 • Interval 9.12 to 20.1	13.21 hours Geometric Coefficient of Variation 21.9 • Interval 6.93 to 18.7

Adverse Events

Tamsulosin HCl (Test)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Flomax Relief (Reference)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tamsulosin HCl (Test) n=34 participants at risk Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule.	Flomax Relief (Reference) n=34 participants at risk Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).
Nervous system disorders Headache	14.7% 5/34 • Up to 72 hours	2.9% 1/34 • Up to 72 hours

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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