Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

NCT01217190 | Completed Phase 1 Results

• 1 other identifier: OND/CR/020/08-09
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

Conditions

Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced

Keywords

Bioequivalence, safety, and tolerability

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)

  0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

• AUCt

  Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration

  0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

• AUCinf

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

  0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours

Study Arms (2)

Ondansetron ODFS then Zofran ODT

EXPERIMENTAL

Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods

Drug: Ondansetron (ODFS); Drug: Zofran (ODT)

Zofran ODT then Ondansetron ODFS

EXPERIMENTAL

Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods

Drug: Ondansetron (ODFS); Drug: Zofran (ODT)

Interventions

Ondansetron (ODFS) DRUG

Test Article

Also known as: Ondansetron Orally Dissolving Film Strip

Ondansetron ODFS then Zofran ODT; Zofran ODT then Ondansetron ODFS

Zofran (ODT) DRUG

Comparator

Also known as: Zofran Orally Disintegrating Tablet

Ondansetron ODFS then Zofran ODT; Zofran ODT then Ondansetron ODFS

Eligibility Criteria

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

You may qualify if:

• Volunteer should have written informed consent.
• Volunteer healthy adult within 18-45 years of age (inclusive).
• Body mass index of 18.5 kg/m\^2 and 25 kg/m\^2, body weight not less than 50 kg.
• Volunteer must be of normal health.
• Volunteer should have a 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.

You may not qualify if:

• Volunteer doesn't understand the informed consent.
• Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
• Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
• Volunteer who smokes regularly, alcohol or drug abuse
• Volunteer who has taken over the counter or prescribed medications
• Volunteer with clinically significant abnormal values of laboratory parameters.
• Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).

Sponsors & Collaborators

• MonoSol Rx: lead

Study Sites (1)

VIMTA VHS Research Centre

Adyār, Chennai, 600 113, India

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

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

Results Point of Contact

• Title: Medical Affairs
• Organization: Par Pharmaceutical

DrugInfo@strativapharma.com

1-800-828-9393

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: Two period study, two treatment, randomized sequence

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: September 16, 2008
• Primary Completion: September 26, 2008
• Study Completion: October 6, 2008
• Last Updated: July 29, 2020
• Results First Posted: July 29, 2020

Record last verified: 2020-07

Locations

IN (1)