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Healthy VolunteersPhase 1NCT04878315

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

A Phase 1 study testing Capoten and Captopril in people with Healthy Volunteers, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Capoten and Captopril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
13 Feb 2022to 25 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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.

Being tested
Capoten, Captopril
Keywords
Bioequivalence, Capoten, Captopril, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapotenDrug

    Capoten will be administered per the treatment sequence

  • CaptoprilDrug

    Captopril will be administered per the treatment sequence

Study groups in NCT04878315
Study groupRoleWhat they receive
Treatment sequence TRRExperimentalParticipants will receive Capoten (T) in period 1 followed by Captopril (R) in period 2 followed by Captopril (R) in period 3.
Receives: Drug: Capoten; Drug: Captopril
Treatment sequence RTRExperimentalParticipants will receive Captopril (R) in period 1 followed by Capoten (T) in period 2 followed by Captopril (R) in period 3.
Receives: Drug: Capoten; Drug: Captopril
Treatment sequence RRTExperimentalParticipants will receive Captopril (R) in period 1 followed by Captopril (R) in period 2 followed by Capoten (T) in period 3.
Receives: Drug: Capoten; Drug: Captopril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed concentration (Cmax) of Captopril

    Measured: 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

    Measured: Up to 3 weeks

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of Captopril

    Measured: Up to 3 weeks

Secondary outcomes (7)

  1. Time to reach Cmax (Tmax) of Captopril

    Measured: Up to 3 weeks

  2. Terminal elimination halftime (t1/2) of Captopril

    Measured: Up to 3 weeks

  3. Terminal elimination rate constant (lambda-z) of Captopril

    Measured: Up to 3 weeks

  4. Percentage of AUC(0-inf) obtained by extrapolation (%AUCex) of Captopril

    Measured: Up to 3 weeks

  5. Number of participants reporting adverse events (AEs)

    Measured: Up to 3 weeks

  6. Number of participants with abnormal hematology and biochemistry parameters

    Measured: Up to 3 weeks

  7. Number of participants with abnormal electrocardiograms (ECGs) and vital signs findings

    Measured: Up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start13 Feb 2022 (estimated)
  3. Primary completion25 Mar 2022 (estimated)
  4. Study completion25 Mar 2022 (estimated)

Why it stopped: Internal sponsor decision to terminate project prematurely based on a waiver granted by Egypt EDA (Egyptian drug authority). No subjects were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a 3-period, 2-treatment, 3-sequence, partially replicated crossover study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878315
Sponsor's protocol ID
213048
Status last verified
Jan 2023
First submitted
4 May 2021
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capoten and Captopril in people with Healthy Volunteers, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed concentration (Cmax) of Captopril (time frame: Up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.

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Clinical Trial NCT04878315 | AzTrials