Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01829893
Brief Summary:
To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
Detailed Description:
This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.
For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. Participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. Plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.
Study:
NCT01829893
Study Brief:
Protocol Section:
NCT01829893