WHO ICTRP trial
A Bioequivalence study of a randomized, open-label, single dose, two-way…
TCTR20211223003 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20211223003 |
|---|---|
| Public title | A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Drospirenone 3 mg plus Ethinyl estradiol 0.03 mg film coated tablets relative to YASMIN in healthy Thai female volunteers under fasting condition |
| Scientific title | A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Drospirenone 3 mg plus Ethinyl estradiol 0.03 mg film coated tablets relative to YASMIN in healthy Thai female volunteers under fasting condition |
| Primary sponsor | Bio-innova and Synchron.Co.,Ltd |
| Registry | Thai Clinical Trials Registry (TCTR) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | Thailand |
| Conditions | Healthy subjects Bioequivalence Drospirenone Ethinyl estradiol;Bioequivalence Drospirenone Ethinyl estradiol |
| Interventions | The new generic products which were recently developed. Volunteer will receive a single dose of 2 tablets of Drospirenone 3 mg plus Ethinyl estradiol 0.03 mg film coated tablets of either test or reference with 250 mL of drinking water… |
| Registration date | Dec 23, 2021 |
| Target size | 32 |
| Secondary IDs | Nil Known |
| Registry page | thaiclinicaltrials.org |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: