Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition

Fed Clinical Trial

Official title:

A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Ondansetron Tablets USP 8 mg With Zofran® 8 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578265
• Other study ID #: Ipca/ARL/127
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2012
• Last updated: April 13, 2012
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: IPCA Laboratories Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.

Description:

Objective of this pivotal study was to assess the bioequivalence between Test Product:

Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zofran® (Ondansetron hydrochloride) 8 mg Tablets of M/s GlaxoSmithKline, under fed condition in normal, healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 48 healthy adult subjects. In each study period, a single 8 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male and female human subjects, age in the range of 18 - 45 years.

2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.

3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).

4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).

5. Willingness to follow the protocol requirements as evidenced by written informed consent.

6. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.

7. No history of drug abuse in the past one year.

8. Non-smokers and non-alcoholics.

9. For female subject is child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies,Diaphragm, Intrauterine device and Abstinence.

OR

• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. Known history of hypersensitivity to Ondansetron hydrochloride, or related drugs.

2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.

3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.

4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.

5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.

6. History of malignancy or other serious diseases.

7. Refusal to abstain from food for at least ten (10.00) hours prior to receiving the high-fat and high-calorie breakfast and for at least four (04.00) additional hours post-dose in each study period.

8. Any contraindication to blood sampling or difficulty in accessibility of veins.

9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.

10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.

11. Blood donation within 90 days prior to the commencement of the study.

12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.

13. Found positive in breath alcohol test done before check-in for each study period.

14. Found positive in urine test for drugs of abuse done before check-in for each study period.

15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.

16. History of problem in swallowing Tablet(s).

17. Female subject, demonstrating positive urine pregnancy test at the time of screening.

18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.

19. Female subject, currently breast feeding or lactating.

20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fed

Intervention

Drug:
• Ondansetron Tablets USP 8 mg
8 mg tablet once a day
• Ondansetron Hydrochloride
8 mg tablet once a day

Locations

Country	Name	City	State
India	Accutest Research Lab (I) Pvt. Ltd.	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
IPCA Laboratories Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence is based on Cmax and AUC parameters.	Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00 and 48.00 hours post-dose.	5 months	No