WHO ICTRP trial
Bioequivalence study comparing Nevirapine Prolonged Release 400 mg tablets…
CTRI/2016/10/007330 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2016/10/007330 |
|---|---|
| Public title | Bioequivalence study comparing Nevirapine Prolonged Release 400 mg tablets (Hetero Labs Limited) to reference drug Viramune Prolonged-Release Tablets 400 mg under fasting conditions in adult HIV-I Infected Patients stabilized on Nevirapine |
| Scientific title | A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single/multicentre, multiple dose (steady state), two-way crossover, oral bioequivalence study of Nevirapine 400 mg Prolonged-Release Tablets manufactured by Hetero Labs Limited, India and Viramune 400 mg prolonged-release… |
| Primary sponsor | Hetero Labs Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: null- HIV Patients |
| Interventions | Intervention1: Nevirapine Tab.: Nevirapine Extended Release Tablet 400 mg of Hetero lab. Oral, Once daily for 08 Days Control Intervention1: Viramune® XR: Viramune 400 mg prolonged-release tablets of Boehringer Ingelheim International… |
| Registration date | Apr 10, 2016 |
| Target size | 38 |
| Secondary IDs | 127-15-EM 00 27 Oct 2015 |
| 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: