Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tizanidine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Tizanidine HCl 4 mg | EXPERIMENTAL | Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited |
| Zanaflex | ACTIVE_COMPARATOR | Zanaflex 4 mg Tablets |
| Name | Type | Description |
|---|---|---|
| Tizanidine | DRUG | Tizanidine HCl Tablets 4 mg |
Inclusion Criteria: Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Web site). Subjects must meet all of the following criteria in order to be included in the study: *...
Tizanidine is a small molecule being studied in healthy volunteers. It is in Phase 1 clinical development by Dr. Reddy's Laboratories Ltd. The ongoing research focuses on bioequivalence studies of Tizanidine HCl tablets, which are typically used to manage muscle spasticity, though the current trials are conducted in healthy subjects.
Tizanidine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of its Tizanidine HCl tablets.
Tizanidine is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The current Phase 1 trials are focused on assessing bioequivalence in healthy volunteers, which is an early stage of clinical testing.
Tizanidine has two completed Phase 1 clinical trials. The first, NCT01065987, is a bioequivalence study of Tizanidine HCl 4mg tablets under fed conditions with 24 participants. The second, NCT01146028, is a bioequivalence study of Tizanidine HCl 4mg tablets under fasting conditions with 42 participants. Both were conducted in Canada.
Tizanidine is not FDA approved. It is currently in Phase 1 clinical development as an investigational drug. The completed trials are bioequivalence studies in healthy volunteers, which are part of the early stages of the drug development process before seeking regulatory approval.