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 being studied in healthy volunteers. The clinical trial listed is a bioequivalency study of Ranitidine Tablets 300 mg under fasting conditions. It is being developed by Dr. Reddy's Laboratories Ltd and is currently in Phase 1 clinical development.
Ranitidine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's bioequivalence in healthy subjects.
Ranitidine is in Phase 1 clinical development. The only listed trial, NCT01131702, is a Phase 1 bioequivalency study that has been completed. The drug is investigational and has not been approved for any indication.
Ranitidine has one clinical trial, NCT01131702, titled 'Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions.' This Phase 1 study enrolled 24 healthy volunteers in Canada and has been completed. The trial was randomized and active-controlled.
Ranitidine is not FDA approved based on the available information. It is an investigational drug currently in Phase 1 clinical development. The completed trial was a bioequivalency study in healthy volunteers, and no approval status has been established.