At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Clindamycin 300 mg capsule +1 moredrug
Likely dose
Clindamycin 300 mg capsule (1 x 300 mg) or Cleocin HCl 300 mg capsule (1 x 300 mg)AI-extracted
Key inclusion· 4
- ✓Healthy male or female subject
- ✓Age 18 to 65 years
- ✓Non-smoker
- ✓Capable of informed consent
Key exclusion· 11
- ✕Clinically significant illness within 4 weeks prior to drug administration
- ✕Clinically significant surgery within 4 weeks prior to drug administration
- ✕History of allergic reactions to clindamycin or related drugs (e.g., lincomycin)
- ✕Abnormal ECG or vital signs (SBP <90 or >140 mmHg, DBP <50 or >90 mmHg, HR <50 or >100 bpm)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Clindamycin 300 mg capsule and Cleocin HCl 300 mg capsules for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2003
Primary CompletionNov 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 4, 2009
Enrollment StartNov 1, 2003
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Clindamycin 300 mg capsuledrug
1 x 300 mg
Cleocin HCl 300 mg capsulesdrug
1 x 300 mg