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Completed

NCT Number: NCT02417844

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

Two tamsulosin HClformulations will be tested in fed state

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Health male volunteers 18 years and older

Exclusion criteria

History of hypersensitivity or allergy to IMP or its excipients or any related medication

Treatment and study plan

tamsulosin (Astellas)

Drug

Tamsulosin HCL

Drug

Primary outcomes

  1. Maximum Measured Concentration (Cmax)

    Time frame: 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

    Maximum measured concentration of analyte in plasma (Cmax)

  2. Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)

    Time frame: 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

    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)

  3. Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)

    Time frame: 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

    Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

Secondary outcomes

  1. Time to Maximum Plasma Concentration (Tmax)

    Time frame: 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

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

  2. Terminal Elimination Rate Constant (λz)

    Time frame: 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

    Terminal elimination rate constant in plasma (λz)

  3. Apparent Terminal Elimination Half-life (t1/2)

    Time frame: 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

    Apparent terminal elimination half-life of the analyte in plasma (t1/2)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2015
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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