Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted Conditions

Healthy Clinical Trial

Official title:

An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Rabeprazole Sodium Delayed Release Tablets 20 mg (Test, Torrent Pharmaceuticals Limited., India) Versus Aciphex® (Rabeprazole Sodium) Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA) in Healthy Human Volunteers Under Fasting Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990378
• Other study ID #: PK-10-066
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2013
• Last updated: November 15, 2013

Study information

• Verified date: November 2013
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period during fasted study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male human volunteers within the age range of 18 to 50 years

• A body mass index within 18-25 Kg/m2

• Given written informed consent to participate in the study

• Absence Of disease markers of HIV 1& 2, hepatitis B & C virus and RPR.

• Absence of significant disease or clinically' significant abnormal laboratory values on laboratory evaluation, medical history and medical examination during the screening

• A normal 12 lead ECG.

• A normal chest X-ray (FA view)

• Comprehension of the nature and purpose'of the study and compliance with the requirement of the entire protocol

• No history or no evidence of hypersensitivity to rabeprazole substituted benzimidazoles or to any component of the formulation

• No history of Anaphylaxis arid Angioedema

• No history or presence of gastric malignancy

• No history of significant systemic diseases

• No history of psychiatric disorders

• No history of addiction to any recreational drug or drug dependence

• No donation of blood(one unit or 350 mL) within 90 days prior to study check-in

• No participation in any clinical study within the last 90 days

• No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations' vitamins and natural products used for therapeutic benefits), within two weeks prior to study check-in

• No history of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to study check-in

• No family history of neurological disorders

• Not consumed alcohol and xanthin containing food and beverages, (chocolates, tea,coffee or cola drinks) cigarettes and tobacco products for at least 48.0 hours prior to study check-in for each period.

• Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Cannabinoids and Barbiturates) in urine during the day of study check-in of each period

• Not consumed grapefruit(mosumbi/sweet lime) juice within the 48.0 hours prior to study check-in

• Negative alcohol breath analysis during the study check-in of each period

Exclusion Criteria:

• History of seizures

• Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study

• History of alcohol consumption for more than two units/day (1 unit=30 mL of spirit/or 1 pint of beer), or having consumed alcohol within 48.0 hours prior to check-in

• High caffeine (more than 5 cups of coffee or tea/day) or tobacco (mote than 9 cigarettes/beedies/cigars per day) consumption

• History of difficulty with donating blood or difficulty in accessibility of veins

• An unusual or abnormal diet for whatever reason e.g. because of fasting due to religious reasons

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rabeprazole sodium 20 mg Delayed Release tablet

Locations

Country	Name	City	State
India	AXIS Clinicals Limited	Miyapur	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence based on Composite of Pharmacokinetics	bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.	plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration	No