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Olanzapine OD · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Olanzapine OD Tablets 5 mg | EXPERIMENTAL | Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited |
| Zyprexa Zydis 5 mg Tablets | ACTIVE_COMPARATOR | Zyprexa Zydis 5 mg Tablets of Cardinal Health, UK |
| Name | Type | Description |
|---|---|---|
| Olanzapine OD Tablets 5 mg | DRUG | Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years * Non-smokers since at least six months * Willingness to provide written informed consent to participate in the study * Body-mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2, with body weight not less than 50 kg * Absence...
Olanzapine OD is an orally disintegrating tablet formulation of olanzapine, dosed at 5 mg. It is being developed by Dr. Reddy's Laboratories Ltd under ticker RDY. The product is studied as a bioequivalent alternative to existing olanzapine orally disintegrating tablets, evaluated in healthy adult volunteers under fed and fasting conditions.
Olanzapine OD targets dopamine receptors DRD2, DRD3, and DRD4, and serotonin receptors HTR2C and HTR2A. It acts as an antagonist at these receptors. This receptor binding profile is characteristic of olanzapine, a small molecule, and underlies the pharmacological activity of the orally disintegrating tablet formulation.
Olanzapine OD is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical studies evaluating this orally disintegrating tablet formulation of olanzapine at the 5 mg dose.
Olanzapine OD is in Phase 1 clinical development. Its studies are bioequivalence trials conducted in healthy adult volunteers, and the development program consists of completed Phase 1 work rather than later-stage or approved status.
Olanzapine OD has been studied in two completed Phase 1 bioequivalence trials. NCT01503450 evaluated the 5 mg orally disintegrating tablet under fed conditions with 26 enrolled participants, and NCT01503437 evaluated the same tablet under fasting conditions with 22 participants. Both trials were conducted in India in healthy volunteers aged 18 years and older.