NCT02417831

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

Completed Phase 1 Results posted Last updated 27 April 2020

What this trial tests

Phase 1 trial testing tamsulosin capsules in Prostatic Hyperplasia in 34 participants. Completed in 31 May 2015.

Timeline

30 April 2015

Primary endpoint
31 May 2015

31 May 2015

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	30 April 2015
Primary completion	31 May 2015
Estimated completion	31 May 2015

Drugs / interventions tested

• tamsulosin capsules — full drug profile →
• tamsulosin HCl — full drug profile →

Conditions studied

• Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 64, male only, with Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax Primary · 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.

Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.

Group	Value	95% CI
New MR (Test)	21700	± 37.8
Registered MR (Reference)	20520	± 36.7

AUC0-tz Primary · 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.

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.

Group	Value	95% CI
New MR (Test)	241500	± 48.4
Registered MR (Reference)	238200	± 48.0

(AUC0-inf) Primary · 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.

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.

Group	Value	95% CI
New MR (Test)	248200	± 49.4
Registered MR (Reference)	244700	± 48.9

Tmax Secondary · 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.

Time to maximum plasma concentration

Group	Value	95% CI
New MR (Test)	5.004	3.00 – 6.00
Registered MR (Reference)	5.006	3.00 – 8.01

λz Secondary · 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.

Terminal elimination rate constant in plasma (λz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.

Group	Value	95% CI
New MR (Test)	0.05	0.0338 – 0.133
Registered MR (Reference)	0.05	0.0347 – 0.0766

t1/2 Secondary · 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.

Apparent terminal elimination half-life of the analyte in plasma (t1/2) Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.

Group	Value	95% CI
New MR (Test)	13.10	5.22 – 20.5
Registered MR (Reference)	13.52	9.04 – 20.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From drug administration until 7days thereafter for each treatment arm, upto 10 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

New MR (Test)

Serious: 0/34 (0%)

Deaths: —

Registered MR (Reference)

Serious: 0/34 (0%)

Deaths: —

Other adverse events (3 terms — click to expand)

Reaction	System	New MR (Test)	Registered MR (Reference)
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT02417831 adverse events section.

Sponsor's own description

A bio-equivalence of 2 different capsule formulations in fasted subjects

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.