Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

NCT01220167 | Completed Phase 1 Results

• 1 other identifier: OND/CR/051/08/09
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

Conditions

Healthy Participants

Keywords

bioavailability

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum Plasma Concentration (Time to reach maximum concentration)

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

• AUCt

  Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

• AUCinf

  Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Study Arms (3)

Sequence ABC

EXPERIMENTAL

Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.

Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water

Sequence BCA

EXPERIMENTAL

Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.

Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water

Sequence CAB

EXPERIMENTAL

Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.

Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water

Interventions

Ondansetron 8 mg ODFS without water DRUG

Single dose of Ondansetron 8 mg (ODFS) administered without water

Also known as: Test Treatment (A)

Sequence ABC; Sequence BCA; Sequence CAB

Ondansetron 8 mg ODFS with water DRUG

Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water

Also known as: Test Treatment (B)

Sequence ABC; Sequence BCA; Sequence CAB

Zofran ODT (ondansetron 8 mg) without water DRUG

Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water

Also known as: Reference Treatment (C)

Sequence ABC; Sequence BCA; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aquestive Therapeutics: lead

MeSH Terms

Interventions

Ondansetron; Water

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Medical Affairs
• Organization: Par Pharmaceutical

DrugInfo@strativapharma.com

800-828-9393

Study Officials

• Sudershan Vishwanath, MD

  Vimta Labs Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share