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Also known as Dr. Reddy's Laboratories, Diflucan (Pfizer)
Fluconazole · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fluconazole | EXPERIMENTAL | Fluconazole Tablets 200 mg of Dr. Reddy's Laboratories limited. |
| Diflucan | ACTIVE_COMPARATOR | Diflucan 200 mg fluconazole tablets of Pfizer |
| Name | Type | Description |
|---|---|---|
| Fluconazole | DRUG | Fluconazole Tablets, 200 mg |
Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: * alcoholism or drug abuse within...
Fluconazole is an antifungal medicine. The clinical program described here does not list a specific patient indication; the two studies were bioavailability studies conducted in healthy adult male volunteers rather than in patients with an infection. Fluconazole is developed by Dr. Reddy's Laboratories Ltd.
Fluconazole is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the two bioavailability studies of fluconazole 200 mg tablets that make up this clinical program.
Fluconazole is in Phase 1 development in this program. Both trials are Phase 1 bioavailability studies and both are completed, with no active trials remaining. The studies enrolled a combined total of 32 participants.
Fluconazole has been studied in two completed Phase 1 bioavailability trials of fluconazole 200 mg tablets: NCT01511770, conducted under fasting conditions with 17 participants, and NCT01511757, conducted under fed conditions with 15 participants. Both trials took place in Canada and enrolled healthy male volunteers aged 18 years and older.
Both trials were randomized, active-controlled Phase 1 studies in healthy adult male volunteers, and neither was double-blind. NCT01511770 assessed fluconazole 200 mg tablets under fasting conditions in 17 participants, while NCT01511757 assessed the same tablets under fed conditions in 15 participants. Both trials were completed in Canada.