Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Latest Information Update: 08 Jan 2021
Price :
$35 *
At a glance
- Drugs BP 101 (Primary)
- Indications Decreased libido; Female sexual dysfunction
- Focus Adverse reactions
- Sponsors Ivix
- 05 Jan 2021 According to an Ovoca Bio media release, upon confirming the submission, the Minzdrav will automatically commence a review process, which is expected to be a minimum of nine months duration.
- 05 Jan 2021 According to an Ovoca Bio media release, based on the two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study, the company has resubmitted the Marketing Authorisation (MA) to the Russian Ministry of Health (Minzdrav) on 30 Dec 2020. The MA submission was not granted following the identification of issues relating to the chemistry, manufacturing and controls (CMC) and labelling sections of the MA submission dossier.
- 10 Feb 2020 Status changed from active, no longer recruiting to completed.