MedTrace Logo

Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride in Healthy Male Subjects

NCT02266511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-17

No results posted yet for this study

Summary

The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4 mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine facility, and the other is a batch, of equal size, produced at the Norman II facility

Conditions

  • Healthy

Interventions

DRUG

Flomax®, Norman II facility

DRUG

Flomax®, Nishine facility

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-08-31
Primary Completion
1999-09-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266511 on ClinicalTrials.gov