Status:
COMPLETED
Two Way Bioequivalence Study Under Fed Conditions
Lead Sponsor:
MonoSol Rx
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants...
Detailed Description
An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Conta...
Eligibility Criteria
Inclusion
- provide written informed consent.
- healthy adult within 18-45 years of age (inclusive).
- Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
- normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
- 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.
Exclusion
- The study participants were excluded based on the following criteria:
- incapable of understanding the informed consent.
- history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
- volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma .
- smokes regularly more than ten cigarettes daily
- taken over the counter or prescribed medications
- history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.
- history of alcohol or substance abuse within the last 5 years.
- clinically significant abnormal values of laboratory parameters.
- positive urine screen for drugs of abuse at the time of admission check-in for each period.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01217801
Start Date
October 1 2008
End Date
October 1 2008
Last Update
May 2 2017
Active Locations (1)
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1
Vimta VHS Research Centre
Adyār, Chenni, India, 600 113