drugset / Trial / NCT01888224
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
RandomizedCrossoverOpen-labelTreatment
Summary
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male subjects under fed condition.
Timeline
- Start
- 2011-06
- Primary completion
- 2011-06
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isotretinoin | Other / unclassified | 40 mg | Oral |
Indications
No indication recorded.