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Also known as Mysoline
Primidone · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Primidone | EXPERIMENTAL | Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories |
| Mysoline | ACTIVE_COMPARATOR | Mysoline Tablets of Yamanouchi Pharma Technologies Inc, |
| Name | Type | Description |
|---|---|---|
| Primidone | DRUG | Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: 1. Subjects who will provide written informed consent. 2. Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg. 3. Havi...
Primidone is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed, and its therapeutic area is classified as other.
Primidone acts on GABA-A receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It functions as a positive allosteric modulator, meaning it enhances the activity of these receptors. This target class is associated with inhibitory signaling in the central nervous system.
Primidone is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker RDY. The company sponsored the clinical work evaluating the drug, including a bioequivalence study conducted in India.
Primidone is in Phase 1 clinical development. One trial has been completed, and no trials are currently active. The completed study was a Phase 1 bioequivalence trial, so the drug remains investigational and has not been approved by the FDA for any indication based on the available information.
Primidone has been evaluated in one completed clinical trial, NCT01132040, titled a bioequivalence study of Primidone tablets 50 mg under fasting conditions. The trial enrolled 24 healthy male volunteers aged 18 years and older in India. It was randomized and active-controlled, though not double-blind.
Primidone is also known by the brand name Mysoline. Both names refer to the same small molecule drug developed by Dr. Reddy's Laboratories Ltd. The bioequivalence study NCT01132040 evaluated Primidone tablets at a 50 mg dose under fasting conditions in healthy volunteers.