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Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.
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This is a bioequivalence study to compare Capozide (test product [T]) to ACE-Hemmer-ratiopharm (reference product[R]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions.
ACE-Hemmer-ratiopharm®is the registered trademark of Ratiopharm GmbH Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence TRR | Experimental | Participants will receive Capozide (T) in period 1 followed by ACE-Hemmer-Ratiopharm (R) in period 2 followed by ACE-Hemmer-Ratiopharm (R) in period 3. |
|
| Treatment sequence RTR | Experimental | Participants will receive ACE-Hemmer-Ratiopharm (R) in period 1 followed by Capozide (T) in period 2 followed by ACE-Hemmer-Ratiopharm (R) in period 3. |
|
| Treatment sequence RRT | Experimental | Participants will receive ACE-Hemmer-Ratiopharm (R) in period 1 followed by ACE-Hemmer-Ratiopharm (R) in period 2 followed Capozide (T) by in period 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capozide | Drug | Capozide will be administered as per the treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of Captopril and Hydrochlorothiazide (HCTZ) | Up to 3 weeks | |
| Area under the concentration-time curve from administration extrapolated to the last time of quantifiable concentration (AUC[0-t]) of Captopril and HCTZ | Up to 3 weeks | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril and HCTZ | Up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax (Tmax) of Captopril and HCTZ | Up to 3 weeks | |
| Terminal elimination halftime (t1/2) of Captopril and HCTZ | Up to 3 weeks | |
| Terminal elimination rate constant (lambda-z) of Captopril and HCTZ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| C044959 | captopril, hydrochlorothiazide drug combination |
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| ACE-Hemmer-Ratiopharm | Drug | ACE-Hemmer-Ratiopharm will be administered as per the treatment sequence. |
|
| Up to 3 weeks |
| Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril and HCTZ | Up to 3 weeks |
| Number of participants with adverse events (AE) serious AEs | Up to 3 weeks |
| Number of participants with abnormal hematology and biochemistry parameters | Up to 3 weeks |
| Number of participants with abnormal electrocardiograms (ECGs) and vital signs findings | Up to 3 weeks |