Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01159158
First received: July 8, 2010
Last updated: July 12, 2010
Last verified: January 2007
  Purpose

The objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Nateglinide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RANDOMIZED, 2-WAY CROSSOVER, BIOEQUIVALENCE STUDY OF NATEGLINIDE 120 mg TABLET AND STARLIX@ ADMINISTERED AS 1 x 120 mg TABLET IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2007
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nateglinide
Nateglinide Tablets 120 mg of Dr. Reddys Laboratories Limited
Drug: Nateglinide
Nateglinide Tablets 120 mg
Other Name: Starlix tablets 120 mg
Active Comparator: Starlix
Starlix Tablets 120 mg of Novartis
Drug: Nateglinide
Nateglinide Tablets 120 mg
Other Name: Starlix tablets 120 mg

Detailed Description:

Single center, bioequivalence, open-label, randomized, 2-way crossover study. 64 + 4 healthy adult male or female, smokers and/or non-smokers. Single oral dose (1 x 120 mg) in each period with a washout of at least 7 days between doses. Dosing with 240 ml of glucose solution (25%).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, smoker or non-smoker, 18 years of age and older.
  • Capable of consent

Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

  • Clinically significant illnesses within 4 weeks prior to the administration of the 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 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, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse within six months prior to 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, 360 mL of beer, or 45 mL of 40% alcohol),
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to heparin, nateglinide, or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption or hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Smoking more than 10 cigarettes per day.
  • Any food anergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptive) within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 300 mL of whole blood within 30 days,
  • 301 mL to 500 mL of whole blood within 45 days, or
  • more than 500 mL of whole blood within 56 days prior to drug administration.
  • Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
  • Patients affected by Type 1 diabetes or diabetic ketoacidosis (this last condition should be treated with insulin).
  • Breast-feeding.
  • Positive serum pregnancy test at screening.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner within 14 days prior to study drug administration. Acceptable methods of contraception:
  • condom + spermicide;
  • diaphragm + spermicide;
  • intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration);
  • hormonal contraceptives (starting at least 4 weeks prior to study drug administration).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01159158

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Antonio R Pizarro, MD SFBC International, SFBC Miami, Inc. 11190 Biscayne Blvd.Miami, Fl 33181, USA
  More Information

No publications provided

Responsible Party: Vice president- Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01159158     History of Changes
Other Study ID Numbers: 40331
Study First Received: July 8, 2010
Last Updated: July 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014