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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.

NCT02635438 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-10-12

No results posted yet for this study

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

Conditions

  • Oropharyngeal Candidiasis

Interventions

DRUG

Unique Pharmaceutical Laboratories, India

Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days

DRUG

Roxane Laboratories Inc., USA

Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days

Sponsors & Collaborators

  • Unique Pharmaceuticals Ltd, India

    collaborator UNKNOWN

  • THINQ Pharma CRO Ltd.

    collaborator UNKNOWN

  • Thinq Pharma-CRO Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Shalini Kumar, Medical · Director Medical Services, Unique Pharmacutical Laboratories, India (A Division Of J. B. Chemicals and Pharmacuticals Limited)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-09-30
Completion
2018-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635438 on ClinicalTrials.gov