Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions

NCT00836056 | Completed Phase 1 Results

• 1 other identifier: 30312
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Bioequivalence Based on Cmax

  Cmax - Maximum Observed Concentration

  Blood samples collected over 24 hour period

• Bioequivalence Based on AUCinf

  AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)

  Blood samples collected over 24 hour period

• Bioequivalence Based on AUC0-t

  AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration

  Blood samples collected over 24 hour period

Study Arms (2)

Clindamycin (test)

EXPERIMENTAL

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

Cleocin® (reference)

ACTIVE COMPARATOR

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

Interventions

Clindamycin 300 mg capsule DRUG

1 x 300 mg

Clindamycin (test)

Cleocin HCl 300 mg capsules DRUG

1 x 300 mg

Cleocin® (reference)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Clindamycin

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Benoit Girard, M.D.

  Anapharn Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: November 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: August 19, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

CA (1)