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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT01302093
Brief Summary:
This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.
Detailed Description:
The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females (minimum of 18 of either gender). Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 calendar days. In each study period, twenty (20) blood samples for pharmacokinetic analysis and, for the first 8 male and 8 female subjects included in the study (total of 16 subjects), seven (7) blood samples for pharmacodynamic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of thiorphan in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.
Study:
NCT01302093
Study Brief:
Protocol Section:
NCT01302093