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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 drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The company's trials to date have been bioequivalence studies conducted in healthy adult volunteers, comparing tizanidine HCl 4 mg tablets under fasting and fed conditions.
Tizanidine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B, where it acts as an agonist. By binding these receptors, the drug modulates adrenergic signaling. This receptor agonist activity is the basis for its pharmacological profile as a small molecule therapeutic.
Tizanidine is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the clinical studies of tizanidine HCl 4 mg tablets, including the bioequivalence trials conducted in Canada in healthy volunteers.
Tizanidine is in Phase 1 clinical development. Both of its recorded trials are Phase 1 bioequivalence studies, and both have been completed. No later-phase trials are listed, so the program remains at the early clinical stage.
Two completed Phase 1 trials are registered for Tizanidine. NCT01146028 is a bioequivalence study of tizanidine HCl 4 mg tablets under fasting conditions with 42 healthy volunteers in Canada. NCT01065987 is a bioequivalence study of the same tablets under fed conditions with 24 healthy volunteers, also in Canada.
The two completed Tizanidine trials enrolled a total of 66 participants. NCT01146028 enrolled 42 healthy volunteers and NCT01065987 enrolled 24 healthy volunteers. Both studies were randomized, active controlled, and conducted in Canada with participants aged 18 years and older.