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Also known as Ondansetron Hydrochloride
Ondansetron · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ondansetron Hydrochloride Tablets 8 mg | EXPERIMENTAL | Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited |
| Zofran Tablets 8 mg | ACTIVE_COMPARATOR | Zofran Tablets 8 mg of GlaxoSmithKline |
| Name | Type | Description |
|---|---|---|
| Ondansetron Hydrochloride | DRUG | Ondansetron Hydrochloride Tablets 8 mg |
Inclusion Criteria: * Subjects who provide written informed consent. * Subjects who were healthy adults within 18 and 45 years of age (both inclusive). * Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * Subjects who had normal health as determined by medical his...
Ondansetron 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 therapeutic indication for this program is undisclosed, and the therapeutic area is classified as other.
Ondansetron targets HTR3A, which is the 5-HT3A receptor. It acts as an antagonist at this target, meaning it blocks receptor activity. HTR3A is a serotonin receptor, and antagonism of this receptor is the drug's mechanism of action.
Ondansetron is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose ticker symbol is RDY. The company is the sponsor of the clinical program for this drug.
Ondansetron is in Phase 1 clinical development. It is an investigational drug and is not approved based on the development data for this program. Two Phase 1 trials have been completed, and there are currently no active trials.
Ondansetron has been studied in two completed Phase 1 bioequivalence trials: NCT01511718, which evaluated ondansetron hydrochloride 8 mg tablets under fed conditions, and NCT01511705, which evaluated the same tablets under fasting conditions. Both enrolled 26 healthy volunteers in India, for a total enrollment of 52.
Yes, Ondansetron Hydrochloride is another name for Ondansetron. The two names refer to the same drug asset, and the clinical trials for this program used ondansetron hydrochloride tablets.