Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ranitidine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ranitidine Tablets, 300 mg | EXPERIMENTAL | Ranitidine Tablets, 300 mg of Dr. Reddy's Laboratories Limited |
| Zantac Tablets, 300 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ranitidine | DRUG | Ranitidine Tablets, 300 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. Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in...
Ranitidine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is an HRH2 antagonist. The specific therapeutic indication for this asset is undisclosed, and it is currently in Phase 1 clinical development.
Ranitidine targets HRH2, also known as the histamine H2 receptor. It acts as an antagonist at this receptor. This mechanism is the basis for its development as a small molecule therapeutic candidate.
Ranitidine is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program for this asset.
Ranitidine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes one completed Phase 1 trial.
Ranitidine has been studied in one completed Phase 1 trial, NCT01131702, titled a bioequivalency study of ranitidine tablets 300 mg of Dr. Reddy's under fasting conditions. The trial enrolled 24 healthy volunteers in Canada and was active controlled and randomized.
Ranitidine is the active pharmaceutical ingredient in products marketed under the brand name Zantac. Dr. Reddy's Laboratories Ltd developed a ranitidine tablet formulation studied in a bioequivalency trial against a reference product.