Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ziprasidone · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ziprasidone HCL Capsules, 20 mg | EXPERIMENTAL | Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited |
| Geodon Capsules, 20 mg | EXPERIMENTAL | Geodon Capsules, 20 mg of Pfizer Inc |
| Name | Type | Description |
|---|---|---|
| Ziprasidone Hydrochloride | DRUG | Ziprasidone HCL Capsules, 20 mg |
Inclusion Criteria: * Male or female, smoker or non-smoker, 18 years of age and older. * Capable of consent. * BMI between 19.0 and 30.0 kg/m2 inclusively. Exclusion Criteria: * Clinically significant illnesses within 4 weeks prior to the administration of the study medication. * Clinically signi...
Ziprasidone is an investigational small molecule being studied in healthy volunteers. It is being developed by Dr. Reddy's Laboratories Ltd for use in bioequivalence studies, which compare the pharmacokinetics of the drug under fasting and fed conditions. The drug is currently in Phase 1 clinical development.
Ziprasidone is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded under the ticker symbol RDY. The company is conducting Phase 1 bioequivalence studies of Ziprasidone HCL capsules in healthy volunteers in the United States.
Ziprasidone is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, with a total of 94 healthy volunteers enrolled. The drug is investigational and has not been approved by regulatory authorities.
Ziprasidone has two completed Phase 1 clinical trials: NCT01581866, a bioequivalence study of Ziprasidone HCL capsules 20 mg under fasting conditions with 56 participants, and NCT01581879, a similar study under fed conditions with 38 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.
Ziprasidone is the generic name for the drug, and the clinical trials study Ziprasidone HCL (hydrochloride) capsules. The active ingredient is ziprasidone, and the HCL form is the salt used in the capsule formulation. Both names refer to the same drug substance.