Clinical trial NCT01217801: Two Way Bioequivalence Study Under Fed Conditions
Official title: Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Aquestive Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

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 \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Area Under Plasma Concentration
timeFrame: Day 1 and Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Adyar
country: India
facility: Vimta VHS Research Centre
state: Chenni
Study officials:
affiliation: Vimta VHS Research Centre
name: Sudershan Vishwanath
role: STUDY_DIRECTOR
References: