This is a multi-centric, open label, randomized, parallel group, Single Dose Clinical Study to Evaluate the Therapeutic Equivalence of Clotrimazole 500 mg Vaginal Tablet of Actor Pharma, South Africa.

The study will be conducted at 5 sites in India only.

Approximately 100  healthy adult females suffering from Vulvovaginal Candidiasis (50 per arm) will be enrolled in the study (Including dropouts/withdrawals). 80 completed patients excluding screen failures, drop-outs and withdrawals will be considered for data analysis..

The primary objective is to evaluate and compare the therapeutic cure rates defined as clinical cure (resolution of clinical signs and symptoms) and mycological cure (negative microscopy and negative culture) at 3±1 days and 14±2 days of Clotrimazole 500 mg Vaginal Tablet versus Canesten^® (Containing Clotrimazole 500 mg) Vaginal Tablet in healthy adult females suffering from Vulvovaginal Candidiasis.

.Secondary objective is to monitor the adverse events and to ensure the safety of patient.

The main inclusion criteria for the study are Female patients should be of age between 18 to 45 years.and should have a primary diagnosis of Vulvovaginal Candidiasis (VVC).

The test drug used will be Clotrimazole 500 mg Vaginal Tablet of Actor Pharma, South Africa whereas the reference drug is Canesten^® (Containing Clotrimazole 500 mg) Vaginal Tablet of Bayer, South Africa

Enrolled patients will receive single dose of either test drug or reference drug, the drug will be administered by inserting one tablet into the vagina (Intra vaginal) at bedtime on Day 0 as per the computer generated randomization sequence.

Duration of Protocol Therapy is 1 day and duration of patient participation is approximately 16±2 days [dosing (Day 0) and Follow-up at 3±1 days and 14±2 days after administration of the vaginal tablet.]

Patients fulfilling inclusion/exclusion criteria at the time of screening would be subjected to medical screening (Day-2). Screening will include, clinical evaluation and history of medication used in last 1 year. The Patient physical examination will be performed including vaginal pH, speculum examination of the vagina, KOH preparation and it will be evaluated by investigators. A vaginal specimen will be obtained for culture and susceptibility testing results. Blood and urine samples will be collected for baseline chemistry, hematology and urinalysis tests. All the results from these procedures will be documented in e-CRF. During treatment visit 2 (Day 0) Vital signs, General examination and AE monitoring will be done on visit 2. Symptoms Relief Card will be filled by investigator. Patient Diary will be provided to patient. All the data from Patient Diary will be recorded in e-CRF in every visit by the investigator. The follow up visit ( post-treatment contact) will be initiated by the investigator at 2, 4, 6 and 8 days after the beginning of treatment. The Follow-up Visit 3 & 4 (Test-of-Cure Visit) will start at 3±1 days after post dose, this will be the First Test-of-Cure visit and second Test-of-Cure visit will be at 14±2 days after post dose. At all these visits clinical examination, vaginal examination and a vaginal semi-quantitative culture will be recorded by the investigators. Speciation and susceptibility testing will be done on all positive cultures.

Primary  endpoint  of  the  study  is  the  proportion  of  patient  with  therapeutic  cure,  defined  as  both  mycological cure and clinical cure, at the test-of-cure visits conducted on study days and Secondary endpoints will be monitored as safety outcomes. Safety assessments can be limited to local description of toxicity.  However, where appreciable systemic absorption occurs, hematology, chemistry, and urine laboratory testing will be performed as per investigators discretion.