Clinical trials: Bio-equivalence Study
Japanese Healthy Adult Male Participants
A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male…
- Trial name
- NCT03042299
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Subjects, Human Volunteers
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.
- Conditions
- Healthy Subjects, Human Volunteers, Healthy Participants, Bioequivalence
- Trial name
- NCT05519514
- Testing
- Cortiment, Budesonide
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott
Healthy
A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma…
- Trial name
- NCT02953535
- Testing
- Magicbuvir, Sovaldi (fist dose), Sovaldi (second dose)
- Where
- Egypt
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Subjects
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.
Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA.
- Trial name
- NCT02962310
- Testing
- Torrent's Rosuvastatin Calcium Tablets 40 mg, Crestor 40 mg Tablets of AstraZeneca LP, USA
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence, Bioavailability
Bio-equivalence Study
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
- Trial name
- NCT01638143
- Testing
- MenaQ7 M-1500 capsules, Gnosis P-1000 capsules, Gnosis M-1500 capsules
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Schizophrenia, Bipolar Disorder
Bio-equivalence Study Between SAPHRIS and Asenapine
This is a Multiple-dose, steady state, three-way reference-replicated crossover study. The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.
- Trial name
- ASN (NCT01948024)
- Testing
- SAPHRIS, Asenapine
- Where
- 7 sites in United States
- Volunteers
- 65 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Osteoporosis
HDDO-1614 Bio Equivalence Study
A randomized, open-label, single-dose, crossover study
- Trial name
- NCT03382314
- Testing
- HDDO-1614, Bazedoxifene / Cholecalciferol
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Healthy
A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet
The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy…
- Trial name
- NCT01900587
- Testing
- Tapentadol ER Tamper-resistant Formulation (TRF), Tapentadol ER Prolonged-Release 2 (PR2)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
ATS-1 Needle Free Injection Device Study-a Device for Administering r-hGH (Saizen) to Treat Growth Hormone Deficiency
This study was a Phase I, open label, randomized, 2-period, 2-sequence, crossover study designed to assess the relative bioavailability of Saizen administered by the ATS-1 needle-free injection device and a standard needle and…
- Trial name
- NCT00407472
- Testing
- ATS-1 needle free device
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- EMD Serono
Bioequivalence, Safety
Oral Bio-equivalence Study
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects…
- Trial name
- NCT05145621
- Testing
- Fingolimod 0.5 mg capsules- Test drug
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.