Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions

NCT01131702 | Completed Phase 1 DMC

• 1 other identifier: 02399
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Ranitidine

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Ranitidine Tablets, 300 mg

EXPERIMENTAL

Ranitidine Tablets, 300 mg of Dr. Reddy's Laboratories Limited

Drug: Ranitidine

Zantac Tablets, 300 mg

ACTIVE COMPARATOR

Drug: Ranitidine

Interventions

Ranitidine DRUG

Ranitidine Tablets, 300 mg

Also known as: Zantac 300 mg tablets of Glaxosmithkline

Ranitidine Tablets, 300 mg; Zantac Tablets, 300 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Web site. Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:
• Subjects will be females and/or males, non-smokers, 18 years of age and older.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illnesses within 4 weeks of the administration of study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical sub investigator would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
• Subjects with BMI ≥ 30.0.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
• History of-drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
• History of allergic reactions to ranitidine or other Hr receptor antagonists (e.g.cimetidine, famotidine, nizatidine).
• History of allergic reactions to heparin.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates. carbamazepine. phenytoin. glucocorticoids rifampin/rifabutin;examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin ketoconazole, MAO inhibitors, neuroleptics, verapamil. quinidine) within 30 days prior to administration of the study medication.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm Inc.

Montreal, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Ranitidine; halofantrine

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eric Bicrell, M.D.

  Anapbarm Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: January 1, 2003
• Primary Completion: February 1, 2003
• Study Completion: March 1, 2003
• Last Updated: June 9, 2010

Record last verified: 2010-06

Locations

CA (1)