Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nabumetone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Nabumetone | EXPERIMENTAL | Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited |
| Relafen | ACTIVE_COMPARATOR | Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. |
| Name | Type | Description |
|---|---|---|
| Nabumetone | DRUG | Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited |
| Relafen | DRUG | Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC. |
Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects who will provide written informed consent * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Having a Body Mass I...
Nabumetone is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers to assess bioequivalence of its 750 mg tablets.
Nabumetone is being studied in healthy volunteers for bioequivalence purposes. The clinical trials are not focused on treating a specific disease but rather on comparing the pharmacokinetics of Dr. Reddy's 750 mg tablets under fasting and fed conditions.
Nabumetone is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange with the ticker RDY. The company is conducting Phase 1 bioequivalence studies for this drug.
Nabumetone is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, both involving healthy volunteers, with a total enrollment of 74 participants.
Nabumetone has two completed Phase 1 trials: NCT01164813, a bioequivalence study of 750 mg tablets under fasting conditions with 44 participants, and NCT01164826, a similar study under fed conditions with 30 participants. Both were conducted in India.
Nabumetone is being studied as a generic version of the reference drug. The trials are designed to demonstrate bioequivalence of Dr. Reddy's 750 mg tablets to the innovator product, which is a standard requirement for generic drug approval.