Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted Conditions
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT01990378
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bioequivalence based on Composite of Pharmacokinetics 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AXIS Clinicals Limited
🇮🇳Miyapur, Hyderabad, India