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Diclofenac Under Fasting Conditions · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical) |
| 2 | EXPERIMENTAL | Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical) |
| 3 | ACTIVE_COMPARATOR | Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) |
| Name | Type | Description |
|---|---|---|
| Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical) | DRUG | - |
| Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical) | DRUG | - |
| Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) | DRUG | - |
| Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) | DRUG | - |
| Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) | DRUG | - |
| Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Diclofenac Under Fasting Conditions refers to diclofenac sodium tablets studied in Phase 1 bioavailability trials in which healthy adult male volunteers received the drug under fasting conditions. The trials evaluated 50 mg and 75 mg enteric-coated tablet formulations in the context of inflammation. Diclofenac is a small molecule drug.
Diclofenac Under Fasting Conditions is studied in the therapeutic area of inflammation. The clinical trials listed for this asset enrolled healthy adult male volunteers to assess relative bioavailability of diclofenac sodium enteric-coated tablets under fasting conditions, rather than to treat patients with an active inflammatory condition.
Diclofenac Under Fasting Conditions targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It is classified as an inhibitor of these targets. By inhibiting PTGS1 and PTGS2, diclofenac reduces prostaglandin synthesis, which underlies its anti-inflammatory activity.
Novartis AG, which trades under the ticker NVS, is the developer associated with Diclofenac Under Fasting Conditions. The asset covers diclofenac sodium 50 mg and 75 mg enteric-coated tablet formulations evaluated under fasting conditions in Phase 1 bioavailability studies.
Diclofenac Under Fasting Conditions is in Phase 1. Both listed trials are completed, with no active trials remaining, and total enrollment across the two studies was 36 participants. The program is an investigational bioavailability assessment rather than a late-stage clinical development program.
Two completed Phase 1 trials are registered: NCT00914160, which assessed the relative bioavailability of diclofenac sodium 50 mg enteric-coated tablets, and NCT00913887, which assessed the 75 mg enteric-coated tablets. Each trial enrolled 18 healthy adult male volunteers aged 18 years and older.