Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00836004
First received: February 3, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.


Condition Intervention Phase
Healthy
Drug: Clindamycin 300 mg capsule
Drug: Cleocin HCl 300 mg capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin Hcl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 24 hour period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clindamycin (test)
Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
Drug: Clindamycin 300 mg capsule
1 x 300 mg
Active Comparator: Cleocin® (reference)
Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
Drug: Cleocin HCl 300 mg capsules
1 x 300 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

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

Inclusion Criteria:

  • Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age.
  • Non-child-bearing potential female subject is defined as follows:

    1. Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
    2. Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
  • Capable of consent.

Exclusion Criteria:

  • 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 the 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.
  • EGC abnormalities (clinically significant) or vital sign abnormalities(systolic blood pressure lower than 90 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.
  • BMI≥ 30.0kg/m2.
  • 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) or positive alcohol breath test at screening.
  • 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 clindamycin or other related drugs (e.g. lienomycin).
  • 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.

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, haematologic, 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 supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Difficulty to swallow study medication.
  • Use of any tobacco products in the 90 days preceding drug administration.
  • Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Subinvestigator, contraindicate the subjects's participation in this study.
  • A depot injection or an implant of any drug 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 prior to administration of the study medication as follows:

    1. less than 300 mL or whole blood within 30 days,
    2. 300 mL to 500 mL of whole blood within 45 days,
    3. more than 500 mL of whole blood within 56 days prior to drug administration.
  • Intolerance to venipunctures.
  • Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
  • Subjects unable to understand or unwilling to sign the Informed Consent Form.
  • Clinically significant history of diarrhea subsequent to administration or antibacterial agents or antibiotics.
  • Additional exclusion criteria for females only:

    1. Breast-feeding subject.
    2. Positive urine pregnancy test at screening
    3. Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 says prior to study drug administration. Acceptable methods of contraception:

      1. condom + spermicide,
      2. diaphragm + spermicide,
      3. intra-uterine contraceptive devise (placed at least 4 weeks prior to study drug administration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836004

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Benoit Girard, M.D. Anapharn Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00836004     History of Changes
Other Study ID Numbers: 30313
Study First Received: February 3, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014