N/A
Completed N=40
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Depression
Source: ClinicalTrials.gov NCT01107353 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Bioequivalence Determined by Statistical Comparison Cmax — 11.5; 11.3 ng/mL
Summary
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence Determined by Statistical Comparison Cmax |
11.5; 11.3 | — |
Eligibility Criteria
Inclusion Criteria
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to imipramine pamoate or any comparable or similar product.
Data sourced from ClinicalTrials.gov (NCT01107353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.