WHO ICTRP trial
Bioequivalence study of Obeticholic Acid in Healthy human subjects
CTRI/2021/02/030875 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/02/030875 |
|---|---|
| Public title | Bioequivalence study of Obeticholic Acid in Healthy human subjects |
| Scientific title | An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose oral bioequivalence study of Obeticholic acid 10 mg tablet (T) Manufactured by G.C.Chemie Pharmie Ltd at M/s. Steril-Gene Life Science (P) Ltd., No. 45, Mangalam Main Raod, Mangalam Village… |
| Primary sponsor | G C Chemie Pharmie Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Interventions | Intervention1: Obeticholic Acid 10mg: Maximum Dosage: 10 mg once daily Route: Oral Frequency: OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times thehighest recommended dosage), as early as one month after starting treatment with… |
| Registration date | Jan 2, 2021 |
| Target size | 24 |
| Secondary IDs | S-19-481 V: 01; Dated: 06.08.2020 |
| Registry page | ctri.nic.in |
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: