WHO ICTRP trial

A Bioequivalence study of a randomized, open-label, single dose, fully replicate…

TCTR20200120004 · Thai Clinical Trials Registry (TCTR) · Not Recruiting

Key facts

Trial ID TCTR20200120004
Public title A Bioequivalence study of a randomized, open-label, single dose, fully replicate crossover design with four-period, two-treatment and two-sequence of Atorvastatin 80 mg tablets relative to Lipitor(R) 80 mg tablets in healthy Thai volunteers under fasting condition
Scientific title A Bioequivalence study of a randomized, open-label, single dose, fully replicate crossover design with four-period, two-treatment and two-sequence of Atorvastatin 80 mg tablets relative to Lipitor(R) 80 mg tablets in healthy Thai volunteers under fa
Primary sponsor Bio-innova and Synchron.Co.,Ltd
Registry Thai Clinical Trials Registry (TCTR)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 0
Countries Thailand
Conditions Bioequivalence study Bioequivalence study Atorvastatin;Bioequivalence study Atorvastatin
Interventions A randomized, open-labeled, single-dose, fully replicate crossover design with four-period, two-treatment and two-sequence under fasting conditions and at least 7 days washout period between the doses.,A randomized, open-labeled…
Registration date Jan 20, 2020
Target size 30
Registry page thaiclinicaltrials.org

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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