Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741623
Other study ID # Ipca/ARL-12/147
Secondary ID
Status Completed
Phase Phase 1
First received December 1, 2012
Last updated December 1, 2012
Start date August 2012
Est. completion date November 2012

Study information

Verified date December 2012
Source IPCA Laboratories Ltd.
Contact n/a
Is FDA regulated No
Health authority India: Ministry of HealthUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult human subjects.


Description:

Objective of this pivotal study was to assess the bioequivalence between Test Product: Bisoprolol Fumarate Tablet 10 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals Inc., USA under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 24 healthy adult subjects. In each study period, a single 10 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 15 days including washout period of at least 10 days between administrations of study drug in each study period.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).

2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.

3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).

4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).

5. Willingness to follow the protocol requirements as evidenced by written informed consent.

6. Subject willing to give written informed consent.

7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.

8. No history of drug abuse in the past one year.

9. Non-smokers and non-alcoholics.

10. For female subject

- was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.

OR

- was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.

2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.

3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.

4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.

5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.

6. History of malignancy or other serious diseases.

7. Refusal to abstain from food for at least 10.00 hours prior to study drug administration and for at least 04.00 hours post-dose, in each study period.

8. Any contraindication to blood sampling or difficulty in accessibility of veins.

9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.

10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.

11. Blood donation within 90 days prior to the commencement of the study.

12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.

13. Found positive in breath alcohol test done before check-in for each study period.

14. Found positive in urine test for drugs of abuse done before check-in for each study period.

15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.

16. History of problem in swallowing Tablet(s).

17. Female subject, demonstrating positive urine pregnancy test at the time of screening.

18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.

19. Female subject, currently breast feeding or lactating.

20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bisoprolol Fumarate Tablet 10 mg
10 mg tablet once a day
Bisoprolol
10 mg tablet once a day

Locations

Country Name City State
India Accutest Research Lab (I) Pvt. Ltd. Ahmedabad Gujarat

Sponsors (1)

Lead Sponsor Collaborator
IPCA Laboratories Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose 3 months No
Primary AUC Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose. 3 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03754920 - Prolonged Fasting With Meditation and Mild Physical Exercise N/A
Completed NCT05272332 - Gastric Ultrasound Prior to Extubation
Completed NCT04247464 - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients N/A
Completed NCT01067001 - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study N/A
Completed NCT00757094 - Safety and Feasibility of Fasting While Receiving Chemotherapy N/A
Completed NCT01506713 - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions Phase 1
Completed NCT04514380 - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed NCT05756868 - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05031598 - Long-term Fasting: Multi-system Adaptations in Humans N/A
Recruiting NCT04501393 - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients N/A
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Recruiting NCT04625608 - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH Phase 4
Not yet recruiting NCT02562638 - Pre-Procedural Fasting in Cardiac Intervention N/A
Completed NCT01954836 - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial N/A
Completed NCT01949987 - Does Oral Intake Decreases Postoperative Pain Score in Children N/A
Completed NCT01831700 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions Phase 1
Completed NCT01713647 - Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions Phase 1
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A