WHO ICTRP trial
An Open Label, Randomized, Two-Treatment, Four-Period, Crossover, Fully…
TCTR20221103007 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20221103007 |
|---|---|
| Public title | An Open Label, Randomized, Two-Treatment, Four-Period, Crossover, Fully Replicate BE Study of AVASTAN (40 mg) (Atorvastatin 40 mg Tablets) of GPO, Thailand with LIPITOR (Atorvastatin 40 mg Tablets) of Pfizer Pharmaceuticals LLC, Puerto Rico, in Healthy Subjects under Fasting Conditions |
| Scientific title | An Open Label, Randomized, Two-Treatment, Four-Period, Crossover, Fully Replicate BE Study of AVASTAN (40 mg) (Atorvastatin 40 mg Tablets) of GPO, Thailand with LIPITOR (Atorvastatin 40 mg Tablets) of Pfizer Pharmaceuticals LLC, Puerto Rico, in Healthy Subjects under Fasting Conditions |
| Primary sponsor | The Government Pharmaceutical Organization |
| Registry | Thai Clinical Trials Registry (TCTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | Thailand |
| Conditions | Healthy male and female subjects Healthy male and female subjects Bioequivalence fasting conditions;Healthy male and female subjects Bioequivalence fasting conditions |
| Interventions | Each tablet contains atorvastatin calcium equivalent to 40 mg of atorvastatin. ,Each tablet contains atorvastatin calcium (crystalline form) equivalent to 40 mg of atorvastatin.;Experimental Drug,Active Comparator Drug;AVASTAN (40… |
| Registration date | Mar 11, 2022 |
| Target size | 42 |
| Secondary IDs | Nil Known |
| Registry page | thaiclinicaltrials.org |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: