Clinical TrialID 7189
Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
NCT02559934
Actinic Keratosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7189
- Evidence Id
- 7189
- Core Evidence Id
- 7189
- Source Clinical Trial Id
- 7178
- Herb2 Clinical Trial Id
- HBCT007178
- Nct Id
- NCT02559934
- Title
- Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Actinic Keratosis
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: SR-T100 Gel
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 12
- Outcome Measure
- AUC0-τ,ss;, AUC0-τ,ss was determined by the area under the plasma concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule, sixteen consecutive weeks.|AUMC0-τ,ss, AUMC0-τ,ss was determined by the area under the plasma (first) moment concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule according to the following equation: AUMC0-τ,ss = Σ\[(tn - tn-1)(Cn-1tn-1 + Cntn) /2\], sixteen consecutive weeks.|Cmax,ss;, Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval), sixteen consecutive weeks.|Cmin,ss;, Cmin,ss was determined by the minimum observed plasma concentration at steady state, sixteen consecutive weeks.|Cave,ss, Cave,ss was determined by the average plasma concentration at steady state (the last dosing interval) according to the following equation: Cave,ss = AUCss / dosing interval, sixteen consecutive weeks.|Fluctuation, Fluctuation was determined by the Fluctuation index of concentration at steady state, sixteen consecutive weeks.|Tmax,ss;, Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval), sixteen consecutive weeks.|kel, kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration, sixteen consecutive weeks.|T½;, T½ was determined by the plasma half-life estimated by (0.693/kel), sixteen consecutive weeks.|MRTss, MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss, sixteen consecutive weeks.
- Sponsor Collaborator
- G&E Herbal Biotechnology Co., LTD
- Funded By
- INDUSTRY
- Location
- National Cheng Kung University Hospital, Tainan, 701, Taiwan
- Other Id
- GESRTAKD
- Start Date
- 2015-11
- Primary Completion Date
- 2019-01
- Completion Date
- 2019-05
- First Posted
- 2015-09-25
- Results First Posted
- Last Update Posted
- 2019-07-15
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02559934
- Title Cn
- Title En
- Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
- Bilingual Status
- semi_complete