Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT01161940 |
Recruitment Status :
Completed
First Posted : July 14, 2010
Last Update Posted : July 14, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Nizatidine Drug: Axid | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Fasting Conditions |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | September 2004 |
Actual Study Completion Date : | September 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Nizatidine
Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited
|
Drug: Nizatidine
Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
Other Name: Axid 300 mg Capsules |
Active Comparator: Axid
Axid 300 mg Capsules of Reliant Pharmaceuticals, US
|
Drug: Axid
Axid 300 mg Capsules of Reliant Pharmaceuticals, US |
- Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 Months ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2).
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to communicate effectively with study personnel. Able to give consent for participation in the trial
Exclusion Criteria:
- Known hypersensitivity or idiosyncratic reaction to nizatidine or other related drugs.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Ingestion of a medication at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert/co-investigator.
- Any history or presence of asthma or nasal polyp.
- A recent history of alcoholism (<2years) or of moderate (180 ml/day) alcohol use.
- Smokers, who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scan.
- History of psychiatric disorders.
- A history of difficulty with donating blood.
- Donations of blood (1 unit or 450 ml) within 90 days prior to receiving the first dose of study medication. Note: Incase the blood loss is ≤ 200 L, subject may be dosed after completion of 60 days of blood donation).
- A positive hepatitis screen including hepatitis B surface antigen, anti-HCV and anti-HAV antibodies.
- A positive test result for HIV antibody and/or syphilis.
- The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medication (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study). (Note: If subject had participated in a study in which blood loss is ≤200 mL, subject can be dosed after completion of 60 days of previous study).
- An unusual diet, for whatever reason (eg., low-sodium), for four weeks prior to receiving the study medication and throughout the subjects, participation in the study. In any such case subject will be at the discretion of the Principal Investigator/Medical expert/Co-investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161940
Principal Investigator: | Charu Gautam, M.D | Lambda Therapeutic Research Ltd. |
Responsible Party: | vice President, Research & Development, Dr. Reddy's Laboratories Limited |
ClinicalTrials.gov Identifier: | NCT01161940 |
Other Study ID Numbers: |
090-04 |
First Posted: | July 14, 2010 Key Record Dates |
Last Update Posted: | July 14, 2010 |
Last Verified: | July 2010 |
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