Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug)
Condition: Drug Drug Interaction
Intervention: Digoxin 250 MCG Oral Tablet; Spironolactone 25 mg/ 5 mL S/F Suspension
Intervention description: The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension; The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension
Intervention MeSH terms: Digoxin; Spironolactone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover, drug-drug interaction study in healthy adult human subjects under fasting condition for spironolactone oral suspension (Carospir®)
Masking: None (Open Label)
Masking description: Spironolactone Oral Suspension
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period,
      crossover oral drug-drug interaction study of spironolactone (perpetrator) and Digoxin
      (substrate drug) in healthy adult human subjects under fasting condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy human subjects aged between 20 and 35 years (including both).

          -  Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not
             less than 60 Kgs.

          -  Subjects who were screened at least 48 hours prior to check-in

          -  Subjects with normal health as determined by personal medical history, clinical
             examination, and laboratory examinations including serological tests during the
             screening

          -  Subjects with normal 2D echo

          -  Subjects having normal 12-lead electrocardiogram (ECG) or ECG with no clinical
             significant abnormalities as determined by Investigator.

          -  Subjects having normal chest X-Ray (P/A view) or chest X-ray with no clinically
             significant abnormalities as determined by investigator.

          -  Subjects able to communicate effectively.

          -  Subjects willing to give written informed consent and adhere to all the requirements
             of this protocol.

          -  Additional inclusion criteria for female subjects, Female of childbearing potential
             practicing an acceptable method of birth control for the duration of the study as
             judged by the investigator(s), such as condoms, foams, jellies, diaphragm,
             intrauterine device (IUD), or abstinence: or Postmenopausal for at least 1 year, or
             Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy
             has been performed on the subject).

        Exclusion Criteria:

          -  Subjects having contraindications or hypersensitivity to study drug or related group
             of drugs.

          -  History or presence of any medical condition or disease according to the opinion of
             the physician.

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             gastrointestinal, endocrine, immunological, dermatological, neurological or
             psychiatric disease or disorder.

          -  Subject having QT/ corrected QT interval (QTc) >450 milliseconds

          -  History or presence of significant alcoholism or drug abuse in the past one year.

          -  History or presence of significant smoking (more than 10 cigarettes /day or
             consumption of tobacco products).

          -  Subjects who fail to abstain from consuming any alcoholic products from 48.00 hours
             prior to check-in to till check-out / last sample of the study.

          -  Subjects who fail to abstain from any xanthine-containing food and/or beverages (like
             chocolate, tea, coffee, cola drinks), cigarettes and tobacco containing products and
             grapefruit and/or it's juice from 48.00 hours prior to check-in to till check-out /
             last sample of the study.

          -  Subjects who fail to refrain from pan or pan masala, gutkha, masala (containing beetle
             nut and tobacco) for 48.00 hours prior to check-in to till check-out/last sample of
             the study.

          -  Difficulty with donating blood.

          -  Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg.

          -  Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.

          -  Pulse rate less than 60 beats/minute or more than 100 beats/minute.

          -  Use of any prescribed medication during last two weeks or over-the- counter (OTC)
             medicinal products/ herbal products during the last one week prior to check-in.

          -  Major illness during 90 days before check-in.

          -  Participation in a drug research study within past 90 days of check-in.

          -  Donation of blood (i.e. one unit or 350 mL) in the past 90 days before check-in.

          -  History of unusual diet consumption in the past 3 weeks before check-in.

          -  Additional exclusion criteria for female subjects, Volunteer demonstrating a positive
             pregnancy test. Volunteers who are pregnant, currently breast-feeding or who are
             likely to become pregnant during the study.

        Volunteers who have used implanted or injected hormonal contraceptives anytime during the 6
        months prior to study or used hormonal contraceptives within 14 days before dosing.

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