A Phase 1 interventional study of Capoten and Captopril in Healthy Volunteers, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-27.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This is a bioequivalence study to compare Capoten (test product [T]) versus captopril (reference product [R]) produced by Mylan Pharmaceuticals Spain, in healthy adult participants under fasting condition. Capoten is the registered trademark of SmithKline Beecham Egypt.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Capoten (T) in period 1 followed by Captopril (R) in period 2 followed by Captopril (R) in period 3.
Drug: Capoten · Drug: Captopril
Participants will receive Captopril (R) in period 1 followed by Capoten (T) in period 2 followed by Captopril (R) in period 3.
Drug: Capoten · Drug: Captopril
Participants will receive Captopril (R) in period 1 followed by Captopril (R) in period 2 followed by Capoten (T) in period 3.
Drug: Capoten · Drug: Captopril
Capoten will be administered per the treatment sequence
Captopril will be administered per the treatment sequence
Maximum observed concentration (Cmax) of Captopril
Time frame: 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
Time frame: Up to 3 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril
Time frame: Up to 3 weeks
Time to reach Cmax (Tmax) of Captopril
Time frame: Up to 3 weeks
Terminal elimination halftime (t1/2) of Captopril
Time frame: Up to 3 weeks
Terminal elimination rate constant (lambda-z) of Captopril
Time frame: Up to 3 weeks
Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril
Time frame: Up to 3 weeks
Number of participants reporting adverse events (AEs)
Time frame: Up to 3 weeks
Number of participants with abnormal hematology and biochemistry parameters
Time frame: Up to 3 weeks
Number of participants with abnormal electrocardiograms (ECGs) and vital signs findings
Time frame: Up to 3 weeks
No study locations are listed for this record.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline