Status:
COMPLETED
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
Lead Sponsor:
MonoSol Rx
Conditions:
Nausea and Vomiting, Postoperative
Nausea With Vomiting Chemotherapy-Induced
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight...
Detailed Description
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study cent...
Eligibility Criteria
Inclusion
- Volunteer should have written informed consent.
- Volunteer healthy adult within 18-45 years of age (inclusive).
- Body mass index of 18.5 kg/m\^2 and 25 kg/m\^2, body weight not less than 50 kg.
- Volunteer must be of normal health.
- Volunteer should have a normal ECG, chest X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.
- Criteria:
Exclusion
- Volunteer doesn't understand the informed consent.
- Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
- Volunteer who smokes regularly, alcohol or drug abuse
- Volunteer who has taken over the counter or prescribed medications
- Volunteer with clinically significant abnormal values of laboratory parameters.
- Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).
Key Trial Info
Start Date :
September 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01217190
Start Date
September 16 2008
End Date
October 6 2008
Last Update
July 29 2020
Active Locations (1)
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1
VIMTA VHS Research Centre
Adyār, Chennai, India, 600 113