A Bioequivalence Study of Two Formulations of 2 x 6.25-mg Carvedilol Tablets in Healthy Thai Volunteers under Fasting Conditio

Phase 1

• Conditions: Healthy volunteers

• Registration Number: TCTR20170523005
• Lead Sponsor: T.O. Chemicals (1979) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-23
• Study Completion: 2017-07-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Male/Female must be 18-55 years of age, body mass index (BMI) =
18-25 kg/m2, inclusive.
2. Must be in good health as determined by medical history, vital signs
(blood pressure (systolic blood pressure not lower than 90 or not over
140 mmHg, diastolic blood pressure not lower than 60 or not over 90
mmHg), body temperature, pulse rate, respiratory rate) and physical
examination or showing no clinically significant abnormalities in the
opinion of clinical investigator
3. Screening ECG without clinically significant abnormalities.
4. Screening visit laboratory values of blood test including hematology
(complete blood count (CBC) with differential), Fasting Blood Sugar
(FBS), Blood Urea Nitrogen (BUN), Creatinine (Cr) analysis and liver
function test (aspartate aminotransferase (AST)/alanine
aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP))
must be within the normal range or showing no clinically significant
abnormalities in the opinion of clinical investigator.
5. Urinalysis results within normal limit or showing no clinically
significant abnormalities in the opinion of clinical investigator.
6. Must have serum HbsAg seronegative and anti-HCV negative.
7. Female subject must have serum β-HCG negative.
8. Female subject who is childbearing potential or male subject agrees to
use an acceptable birth control method from visit 1 to the follow up
visit. The acceptable birth control method is defined as a barrier
method of contraception (including condoms, intrauterine device
(IUD), and diaphragm with spermicidal agent) or total abstinence from
sexual intercourse from visit 1 to the follow up visit. Hormonal
contraceptives are not acceptable.
9. Female subject who is non-childbearing potential (hysterectomy, both
ovaries removed, surgically sterilized or postmenopausal (for at least
12 consecutive months of amenorrhea)).
10. Female subjects must agree not to become pregnant for the entire
participation period and must have a negative result for a urine
pregnancy test performing prior to dosing at period 1 and period 2.
11. Non-smokers (never smoked or no smoking within the previous 1
year).
12. Refrain from using herbal medications, dietary supplements (e.g., St.
John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit
or grapefruit juice, or pomelo within 14 days before the first
administration of study drug (Day 1). Subjects must agree to refrain
from these items until the last collection time-point of period 2.
13. Subjects must have ended any medications at least 1 month prior to
study Day 1 and agree to continue their refraining throughout the
follow up period.
14. Subjects must refrain from drinking caffeine and alcohol for at least 72
hours prior to study Day 1 and agree to continue their refraining
throughout the last collection time-point of period 2.
15. Have the ability to understand the requirements of the study and must
voluntarily sign and date an informed consent, approved by an
Independent Ethic Committee (IEC)/Institutional Review Board (IRB),
prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria

1. Known hypersensitivity to carvedilol and its components
2. Past medical history of renal and hepatic insufficiency.
3. Subject has a history of any illness that, in the opinion of the
investigator, might confound the result of the study or pose an
additional risk in administering study drug to the subject. This may
include but is not limited to: a history of relevant drug or food
allergies; history of cardiovascular, gastrointestinal, central nervous
system disease, renal and hepatic impairment; history or presence of
clinically significant illness; or history of mental illness that may affect
compliance with study requirements.
4. Have history of drug abuse in the opinion of the investigator, as judged
by medical history) in the last 12 months.
5. Have positive urine drug abuse testing (methamphetamine (Meth),
morphine (Mor), tetrahydrocannabinol (THC), cocaine (Coc) and
methylenedioxy methamphetamine (MDMA)) at screening visit or
before dose administration at each period.
6. Alcohol abuse or excessive use (in the opinion of the investigator, as
judged by medical history) in the last 12 months.
7. Have positive alcohol breathing test at screening visit or before dose
administration at each period.
8. Female subject is pregnant or breast feeding.
9. Difficulties swallowing tablets whole
10. Difficulties fasting or consuming standard meals
11. Donation or loss of whole blood:
a. ≥ 50 mL and ≤ 499 mL within 30 days prior to dosing
b. ≥ 500 mL within 56 days prior to dosing.
12. Participation in any investigation drug study within 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified