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Open-label, randomized, single dose, two-treatment, two-way crossover study
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The present study is planned to establish bioequivalence of Duodart® 0.5mg/0.4mg manufactured by GlaxoSmithKline to concomitant dosing with separate capsules of dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg formulations commercially available in Russia. The design of the present study relies on data obtained in pivotal bioequivalence study and Russian guidance on high quality bioequivalence studies.
Summary of treatment groups Treatment Sequence Number of subjects
Upon completion of the last dosing session, subjects will be contacted via telephone within approximately 10-14 days for a follow-up inquiry (or visit at the discretion of the investigator) and will be subsequently discharged from the study.
Where multiple measurements/evaluations are scheduled for the same time then the measurements/evaluations will be taken in the following order:
Vital Signs
Orthostatic Vital Signs
PK - Blood Sample Where multiple measurements/evaluations are scheduled for the same time then the study co-coordinator will attempt to ensure that the PK samples are drawn as close to the scheduled time as possible whilst adhering to the order of assessments as described above.
Treatment will be open-label; therefore, blinding procedures are not applicable.
For tamsulosin, the following PK parameters will be computed:
For dutasteride, the following PK parameters will be computed:
Cmax
Tmax
AUC(0-t)
Mean residence time The half-life and AUC(0-∞) will be computed only for tamsulosin because duration of sampling period equal to 72 h is expected to be non-sufficient for reliable computation of half-life and AUC(0-∞) of dutasteride given the complex pharmacokinetics of dutasteride and long half-life of dutasteride at each of two elimination pathways [12].
AEs will be collected from the start of Study Treatment and until the follow-up contact.
SAEs will be collected over the same time period as stated above for AEs. However, any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product will be recorded from the time a subject consents to participate in the study up to and including any follow-up contact. All SAEs will be recorded and reported to GSK within 24 hours
Following dosing, subjects will not be allowed food until 4 hours post dose. Meals will be served at the times outlined in Section 2 (Schedule of Assessments), in a seated position (unless orthostasis detected, in which meals should be served in a semi-recumbent position).
Meals will be served on Days 2 and 3 at approximately the same time as on Day 1.
Subjects will not be allowed to consume the following foods or drinks within 7 days prior to the first dose of study medication until after collection of the final pharmacokinetic blood sample: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
Safety analysis population of this study will consist of all volunteers who took part in at least one study stage.
Data from volunteers who discontinued the study prematurely will be included in the final report, but no included in the pharmacokinetics parameters calculation and statistical analysis.
If the volunteer has not taken any of the study drugs at all, his/her data are not to be included in the statistical analysis.
Descriptive statistics will be used to present the mean value, standard deviation, median value, minimal and maximal value.
Analysis of variance will be done based on the assumption about the log-normal distribution of AUC, Cmax, and Cmax/AUC, and normal distribution of other pharmacokinetics parameters except tmax. The comparison of average values of the investigated and comparator drug parameters is performed with the multiplicative model as a basis and confidence intervals built for the ratio of the corresponding mean values. After the logarithmic transformation these values will be analyzed by analysis of variance (ANOVA).
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35 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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