Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions
Condition: Healthy
Intervention: Clindamycin 300 mg capsule; Cleocin HCl 300 mg capsules
Intervention description: 1 x 300 mg; 1 x 300 mg
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      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 fasting conditions.
    

Eligibility 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 ot 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.