Status:
COMPLETED
Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Lead Sponsor:
Aquestive Therapeutics
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS...
Detailed Description
This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) a...
Eligibility Criteria
Inclusion
- The criteria for inclusion in the study were:
- Study volunteer should provide written informed consent.
- Study volunteer must be a healthy adult within 18-45 years of age (inclusive).
- Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
- Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
- Study volunteer should have a normal ECG, chest X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.
Exclusion
- The criteria for exclusion from the study were:
- Study volunteer incapable of understanding the informed consent.
- Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
- Study volunteer who smokes regularly more than ten cigarettes daily.
- Study volunteer who has taken over the counter or prescribed medications.
- Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01220167
Start Date
August 1 2008
End Date
August 1 2008
Last Update
August 18 2020
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