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Also known as AMNESTEEM, ACCUTANE
Isotretinoin · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Isotretinoin capsules, 40 mg | EXPERIMENTAL | Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd |
| AMNESTEEM | ACTIVE_COMPARATOR | AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc |
| Isotretinoin capsules, 20 mg | EXPERIMENTAL | Isotretinoin Capsules, 20 mg of Dr.Reddy's Laboratories Ltd |
| ACCUTANE | ACTIVE_COMPARATOR | ACCUTANE 20 mg of Roche Laboratories Inc |
| Name | Type | Description |
|---|---|---|
| Isotretinoin | DRUG | Isotretinoin Capsules,40 mg |
Inclusion Criteria: * Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. * Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2. * Not having any...
Isotretinoin is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. Its clinical program to date has focused on bioequivalence and bioavailability testing in healthy adult male volunteers.
Isotretinoin targets the retinoic acid receptors RARA, RARB, and RARG. It acts as an agonist at these receptors, meaning it activates them. This receptor activity is the basis of its pharmacological mechanism as a small molecule agent in clinical development.
Isotretinoin is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor behind the clinical studies registered for this asset.
Isotretinoin is in Phase 1 clinical development. It is an investigational drug and is not approved based on the studies registered to date. All four of its registered trials are Phase 1 studies, and all four have been completed, with no active trials currently listed.
Four completed Phase 1 trials are registered for Isotretinoin: NCT01888341, NCT01888328, NCT01888289, and NCT01888224. These studies evaluated bioequivalence and bioavailability of isotretinoin capsules at 20 mg and 40 mg under fasting and fed conditions, enrolling a total of 163 healthy adult male volunteers across the United States and India.