WHO ICTRP trial
An Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Oral…
TCTR20210521001 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20210521001 |
|---|---|
| Public title | An Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Oral Dose, Crossover BE Study of Rozacor (20 mg) of The Government Pharmaceutical Organization, Thailand with CRESTOR of IPR Pharmaceuticals Inc., Puerto Rico, in Healthy Human Subjects under Fasting Conditions |
| Scientific title | An Open Label, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Oral Dose, Crossover BE Study of Rozacor (20 mg) of The Government Pharmaceutical Organization, Thailand with CRESTOR of IPR Pharmaceuticals Inc., Puerto Rico, in Normal, Healthy, Adults Human Subjects under Fasting… |
| 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 fed conditions;Healthy male and female subjects Bioequivalence fed conditions |
| Interventions | Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin ,Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin;Active Comparator Drug,Experimental Drug;CRESTOR,ROZACOR (20 mg) |
| Registration date | May 21, 2021 |
| Target size | 50 |
| Secondary IDs | Nil Known |
| Registry page | thaiclinicaltrials.org |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: