Healthy
Conditions
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.
Interventions
Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
DRUGOndansetron (ODT)
Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
Sponsors
MonoSol Rx
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Plasma Concentration | Day 1 and Day 7 | Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence. |
Countries
India
Participant flow
Recruitment details
Healthy adult study participants between 18-45 years (inclusive) of age who were willing to participate in the study by providing written informed consent
Participants by arm
| Arm | Count |
|---|---|
| Ondanestron Orally Dissolving Filmstrip Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated. | 24 |
| Ondanestron Orally Disintegrating Tablet Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated. | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Protocol Violation | 1 | 1 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Ondanestron Orally Disintegrating Tablet | Ondanestron Orally Dissolving Filmstrip | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Continuous | 26.78 years STANDARD_DEVIATION 5.8 | 26.78 years STANDARD_DEVIATION 5.8 | 26.78 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment India | 48 participants | 48 participants | 48 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Area Under Plasma Concentration
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Time frame: Day 1 and Day 7
Population: All that completed a period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Film | Area Under Plasma Concentration | 213.7 ng*hr/ml | Standard Deviation 47.8 |
| Tablet | Area Under Plasma Concentration | 225.9 ng*hr/ml | Standard Deviation 49.08 |
Comparison: Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CIp-value: 0.0590% CI: [89.15, 98.63]Regression, Linear