Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01888224 | Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition | PHASE1 | COMPLETED | 61 | — | — | Jun 1, 2011 | Jul 1, 2011 | Jun 27, 2013 | 1 | India |
| NCT01888341 | Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition | PHASE1 | COMPLETED | 41 | — | — | Aug 1, 2002 | Aug 1, 2002 | Jun 27, 2013 | 1 | United States |
| NCT01888289 | Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition | PHASE1 | COMPLETED | 35 | — | — | Jul 1, 2001 | Sep 1, 2001 | Jun 27, 2013 | 1 | United States |
| NCT01888328 | Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition | PHASE1 | COMPLETED | 26 | — | — | May 1, 2001 | Jun 1, 2001 | Jun 27, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Isotretinoin capsules, 40 mg | EXPERIMENTAL | Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd |
| AMNESTEEM | ACTIVE_COMPARATOR | AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc |
| Isotretinoin capsules, 20 mg | EXPERIMENTAL | Isotretinoin Capsules, 20 mg of Dr.Reddy's Laboratories Ltd |
| ACCUTANE | ACTIVE_COMPARATOR | ACCUTANE 20 mg of Roche Laboratories Inc |
| Name | Type | Description |
|---|---|---|
| Isotretinoin | DRUG | Isotretinoin Capsules,40 mg |
Inclusion Criteria: * Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. * Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2. * Not having any...