drugset / Trial / NCT02635438
A Comparative Clinical Trial to Evaluate the Safety and Clinical Equivalence of Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) With Clotrimazole Troche 10mg (Roxane Laboratories Inc., USA) in Subjects With Oropharyngeal Candidiasis.
Phase 3
Unknown
360 enrolled
Thinq Pharma-CRO Pte. Ltd.
THINQ Pharma CRO Ltd. · collabUnique Pharmaceuticals Ltd, India · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The objectives of this study are to compare the efficacy and safety of Clotrimazole troche/ lozenges USP, 10 mg (Unique Pharmaceutical Laboratories, India) vs. Clotrimazole Troche/ Lozenges USP, 10 mg (Roxane Laboratories Inc., USA) in patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture
Timeline
- Start
- 2016-12
- Primary completion
- 2018-09
- Completion
- 2018-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clotrimazole | Unknown | 10 mg | — |