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Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04878315
Recruitment Status : Not yet recruiting
First Posted : May 7, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Capoten Drug: Captopril Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a 3-period, 2-treatment, 3-sequence, partially replicated crossover study
Masking: None (Open Label)
Masking Description: It is an open-label study.
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Three Period, Three Sequence, Partially Replicated Crossover Bioequivalence Study of Two Oral Formulations of Captopril 50 mg Film Coated Tablets in Healthy Adult Participants Under Fasting Conditions
Estimated Study Start Date : December 10, 2021
Estimated Primary Completion Date : January 14, 2022
Estimated Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Captopril

Arm Intervention/treatment
Experimental: Treatment sequence TRR
Participants will receive Capoten (T) in period 1 followed by Captopril (R) in period 2 followed by Captopril (R) in period 3.
Drug: Capoten
Capoten will be administered per the treatment sequence

Drug: Captopril
Captopril will be administered per the treatment sequence

Experimental: Treatment sequence RTR
Participants will receive Captopril (R) in period 1 followed by Capoten (T) in period 2 followed by Captopril (R) in period 3.
Drug: Capoten
Capoten will be administered per the treatment sequence

Drug: Captopril
Captopril will be administered per the treatment sequence

Experimental: Treatment sequence RRT
Participants will receive Captopril (R) in period 1 followed by Captopril (R) in period 2 followed by Capoten (T) in period 3.
Drug: Capoten
Capoten will be administered per the treatment sequence

Drug: Captopril
Captopril will be administered per the treatment sequence




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) of Captopril [ Time Frame: Up to 3 weeks ]
  2. 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 ]
  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril [ Time Frame: Up to 3 weeks ]

Secondary Outcome Measures :
  1. Time to reach Cmax (Tmax) of Captopril [ Time Frame: Up to 3 weeks ]
  2. Terminal elimination halftime (t1/2) of Captopril [ Time Frame: Up to 3 weeks ]
  3. Terminal elimination rate constant (lambda-z) of Captopril [ Time Frame: Up to 3 weeks ]
  4. Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril [ Time Frame: Up to 3 weeks ]
  5. Number of participants reporting adverse events (AEs) [ Time Frame: Up to 3 weeks ]
  6. Number of participants with abnormal hematology and biochemistry parameters [ Time Frame: Up to 3 weeks ]
  7. Number of participants with abnormal electrocardiograms (ECGs) and vital signs findings [ Time Frame: Up to 3 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 50 years of age inclusive
  • Participant does not have a known allergy to the drug under investigation, any of its ingredients or any other related drugs.
  • Normal vital signs after up to 10 minutes resting in supine position or 2 minutes in sitting position: 100 millimeter of mercury (mmHg) =< systolic blood pressure (SBP) <130 mmHg; 70 mmHg =< diastolic blood pressure (DBP) <90 mmHg; 60 beats per minute (bpm) =< Pulse rate (HR) =< 100 bpm.
  • Normal standard 12-lead ECG after 10 minutes resting in supine position in the following ranges; 120 milliseconds (ms)<PR<220 ms, QRS<120 ms, corrected QT interval (QTc)=<450 ms, and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
  • Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participants; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should not exceed 1.25 times the upper laboratory norm, and total bilirubin should not exceed the upper laboratory normal (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
  • Body weight on 45 kilogram (kg) or more and body mass index (BMI) within the range 18.5-30 kilogram per meter square (kg/m^2) (inclusive).
  • Healthy Adult, Male and Female (woman of non-childbearing potential [WONCBP]); a) Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 30 days after the last dose of the study drug. Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed in the protocol; Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant, agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. Contraceptive use by Men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female Participants: is eligible to participate if: Is a WONCBP as defined in the protocol. Additional requirements for testing are listed in the protocol. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Female participants must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
  • Capable of giving signed informed consent as described in the protocol.

Exclusion Criteria:

  • Any history or presence of clinically relevant cardiovascular including history of hypotension and orthostatic hypotension, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular or infectious disease, or signs of acute illness, lactose intolerance.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
  • Blood donation, any volume, within 2 months.
  • Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure >=30 mmHg within 3 minutes when changing from supine to standing position.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the investigational medicinal product (IMP) formulation or allergic disease diagnosed and treated by a physician.
  • History of drug or alcohol abuse. History of regular alcohol consumption within one year of the study defined as: an average weekly intake of >14 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases [more than 4 cups or glasses (average 100 mL) per day].
  • Use of any prescribed medication, over the counter (OTC) medicines or medicinal products during the last two weeks preceding the first dosing and until discharge from the study.
  • Participation in a bioequivalence study or in a clinical study within the last 60 days (2 months) before first study drug administration.
  • Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
  • Positive result on urine drug screen (amphetamines/ methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Participant who has results of laboratory tests which are outside the normal range or hemoglobin (Hb) or red blood cells (RBC) indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH] and mean corpuscular hemoglobin concentration [MCHC]) with deviation outside 5% of the reference range at screening. (Laboratory tests are performed not longer than two weeks before the initiation of the clinical study).
  • Participants who have been on a specific/special diet during the 4 weeks before screening and who cannot agree to eat the set clinical food menu during the study.
  • Difficulty in swallowing tablets.
  • Participants that have a current active Coronavirus disease 2019 (COVID-19) infection, either laboratory confirmed or according to the investigator's medical judgement.
  • Participants known to be in contact with active COVID-19 positive individuals within the past 14 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878315


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04878315    
Other Study ID Numbers: 213048
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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 Criteria: 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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Bioequivalence
Capoten
Captopril
Healthy Volunteers
Additional relevant MeSH terms:
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Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents