Androxal Cmax Formulation A
| Group | Value (ng/mL) | Spread |
|---|---|---|
| 12.5 mg Androxal Formulation A | 0.999 | 0.349 |
| 25 mg Androxal Formulation A | 1.67 | 0.74 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
Experimental
12.5 mg Androxal (formulations A and B)
12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
Experimental
25 mg Androxal (formulations A and B)
25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
Outcomes the sponsor listed as primary.
Androxal Cmax Formulation A
Time frame · 24 hours
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Androxal Cmax Formulation B
Time frame · 24 hours
To determine and compare the PK parameter Cmax between two formulations of Androxal
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/mL) | Spread |
|---|---|---|
| 12.5 mg Androxal Formulation A | 0.999 | 0.349 |
| 25 mg Androxal Formulation A | 1.67 | 0.74 |
| Group | Value (ng/mL) | Spread |
|---|---|---|
| 12.5 mg Androxal Formulation B | 1.08 | 0.42 |
| 25 mg Androxal Formulation B | 1.74 | 0.47 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 12.5 mg Androxal Formulation AA single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2. | – | 0 / 8 | 2 / 8 |
| 12.5mg Androxal Formulation BA single dose of 12.5 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2. | – | 0 / 8 | 0 / 8 |
| 25 mg Androxal Formulation AA single dose of 25 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2. | – | 0 / 8 | 1 / 8 |
| 25 mg Androxal Formulation BA single dose of 25 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2. | – | 0 / 8 | 1 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
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