- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00836004
Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Quebec
-
Sainte-Foy, Quebec, Canada, G1V 2K8
- Anapharm Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
- 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:
- less than 300 mL or whole blood within 30 days,
- 300 mL to 500 mL of whole blood within 45 days,
- 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:
- Breast-feeding subject.
- Positive urine pregnancy test at screening
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:
- condom + spermicide,
- diaphragm + spermicide,
- intra-uterine contraceptive devise (placed at least 4 weeks prior to study drug administration.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clindamycin (test)
Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
|
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
|
1 x 300 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 24 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 24 hour period
|
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 24 hour period
|
Bioequivalence based on AUCinf
|
Blood samples collected over 24 hour period
|
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
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 24 hour period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benoit Girard, M.D., Anapharn Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Clindamycin 300 mg capsule
-
Teva Pharmaceuticals USACompleted
-
Vedic Lifesciences Pvt. Ltd.Not yet recruitingUpper Respiratory Tract InfectionsIndia
-
Centro Universitario de TonaláCompletedDiabetes Mellitus | Periodontitis | Periodontal Pocket
-
Vedic Lifesciences Pvt. Ltd.CompletedAlert Fatigue, Health PersonnelIndia
-
SandozCompleted
-
SandozCompleted
-
VM Oncology, LLCRecruitingSarcoma | Cervical Cancer | Breast Cancer | Adenoid Cystic Carcinoma | Pancreatic Cancer | Ovarian Cancer | Non-Small Cell Lung Cancer | Thymic Carcinoma | Lung Cancer | Mesothelioma | Bladder Cancer | Head and Neck Carcinoma | Any Solid Tumors Progressed After a Prior ImmunotherapyUnited States, Puerto Rico
-
GlaxoSmithKlineCompleted
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, PulmonaryUnited States